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Nicorette White Ice

Package insert / prescribing information
Generic name: nicotine polacrilex
Dosage form: gum, chewing
Drug class: Smoking cessation agents

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

a sodium-restricted diet
heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
high blood pressure not controlled with medication. Nicotine can increase blood pressure.
stomach ulcer or diabetes
history of seizures

Ask a doctor or a pharmacist before use if you are

using a non-nicotine stop smoking drug
taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

mouth, teeth or jaw problems occur
irregular heartbeat or palpitations occur
you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
(For Cinnamon Surge) oral blistering occurs
you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (2 mg)

if you are under 18 years of age, ask a doctor before use
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the gum on your quit day
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

nicotine gum is a medicine and must be used a certain way to get the best results
chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
repeat this process until most of the tingle is gone (about 30 minutes)
do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Directions (4 mg)

if you are under 18 years of age, ask a doctor before use
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the gum on your quit day
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

nicotine gum is a medicine and must be used a certain way to get the best results
chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
repeat this process until most of the tingle is gone (about 30 minutes)
do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider

Other information (White Ice Mint)

(2 mg) each piece contains: calcium 94 mg, sodium 11 mg
(4 mg) each piece contains: calcium 94 mg, sodium 13 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Other information (Original)

each piece contains: calcium 117 mg, sodium 13 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Other information (Cinnamon Surge)

(2 mg) each piece contains: calcium 94 mg, sodium 11 mg
(4 mg) each piece contains: calcium 94 mg, sodium 13 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Other information (Fresh Mint)

(2 mg) each piece contains: calcium 94 mg, sodium 11 mg
(4 mg) each piece contains: calcium 94 mg, sodium 13 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Other information (Mint)

(2 mg) each piece contains: calcium 94 mg, sodium 13 mg
(4 mg) each piece contains: calcium 94 mg, sodium 14 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Other information (Spearmint Burst)

(2 mg) each piece contains: calcium 94 mg, sodium 11 mg
(4 mg) each piece contains: calcium 94 mg, sodium 13 mg
store at 20 - 25oC (68 - 77oF)
protect from light

Inactive ingredients (White Ice Mint)

each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive ingredients (Original)

each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive ingredients (Cinnamon Surge)

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (Fresh Mint)

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

Inactive ingredients (Mint)

each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (Spearmint Burst)

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Questions and comments?

call toll-free 1-800-419-4766

Additional information found on packaging

TO INCREASE YOUR SUCCESS IN QUITTING:

1.
You must be motivated to quit.
2.
Use Enough – Chew at least 9 pieces of Nicorette gum per day during the first six weeks.
3.
Use Long Enough – Use Nicorette gum for the full 12 weeks.
4.
Use with a support program as directed in the enclosed User’s Guide.

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

not for sale to those under 18 years of age
proof of age required
not for sale in vending machines or from any source where proof of age cannot be verified

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

Distributed by

GSK Consumer Healthcare

Warren, NJ 07059

Made in Sweden

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

Principal Display Panel

NDC 0135-0474-02

Nicorette®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint®

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette® 4 mg Gum

100 PIECES, 2 mg EACH

©2016 GSK or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30462XG

Principal Display Panel

NDC 0135-0475-02

Nicorette®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint®

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES, 4 mg EACH

©2016 GSK or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30463XG

Principal Display Panel

NDC 0135-0157-07

Nicorette®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Original

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4mg Gum

110 PIECES, 2 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29545XG

Principal Display Panel

NDC 0135-0158-07

Nicorette®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Original

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette® 2 mg Gum

110 PIECES, 4mg EACH

©2015 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29546XG

Principal Display Panel

NDC 0135-0466-02

Nicorette®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge™

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4mg Gum

100 PIECES, 2 mg EACH

©2016 GSK group of companies or its licensor.

Trademarks are owned by or licensed o the GSK group of companies.

30214XG

Principal Display Panel

NDC 0135-0467-02

Nicorette®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge™

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES, 4 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30215XG

Principal Display Panel

NDC 0135-0225-02

Nicorette®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4 mg Gum

100 PIECES, 2 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29547XI

Principal Display Panel

NDC 0135-0226-02

Nicorette®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette® 2 mg Gum

100 PIECES, 4 mg EACH

©2016 GSK group of companies or tis licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29548XI

Principal Display Panel

NDC 0135-0229-04

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Mint

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4mg Gum

110 PIECES, 2mg EACH

©2014 GSK

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GSK group of companies.

29552XG

Principal Display Panel

NDC 0135-0230-04

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Mint

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2mg Gum

110 PIECES, 4mg EACH

©2014 GSK

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GSK group of companies.

29553XG

Principal Display Panel

NDC 0135-0532-02

Nicorette

nicotine polacrilex gum, 2 mgstop smoking aid

Gum

NEW FLAVOR

Coated FOR BOLD FLAVOR

Spearmint Burst with a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4 mg Gum

100 PIECES, 2 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

101782XC

Principal Display Panel

NDC 0135-0533-02

Nicorette

nicotine polacrilex gum, 4 mgstop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burst with a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES, 4 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

101781XC

Principal Display Panel

NDC 0135-0355-03

Nicorette

nicotine polacrilex gum, 4 mgstop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burst with a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Gum

160 PIECES, 4 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

105941XB

NICORETTE WHITE ICE MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0474
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM BICARBONATE
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE Score no score
Shape SQUARE Size 15mm
Flavor MINT (White Ice Mint) Imprint Code N2
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0474-01 1 BLISTER PACK in 1 CARTON
1 20 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0474-02 1 BLISTER PACK in 1 CARTON
2 100 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0474-05 1 BLISTER PACK in 1 CARTON
3 160 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0474-08 20 GUM, CHEWING in 1 CARTON
5 NDC:0135-0474-14 25 GUM, CHEWING in 1 CARTON
6 NDC:0135-0474-15 8 CARTON in 1 PACKAGE
6 25 GUM, CHEWING in 1 CARTON
7 NDC:0135-0474-17 1 BLISTER PACK in 1 CARTON
7 10 GUM, CHEWING in 1 BLISTER PACK
8 NDC:0135-0474-18 2 CARTON in 1 PACKAGE
8 10 BLISTER PACK in 1 CARTON
8 10 GUM, CHEWING in 1 BLISTER PACK
9 NDC:0135-0474-19 12 BLISTER PACK in 1 CARTON
9 10 GUM, CHEWING in 1 BLISTER PACK
10 NDC:0135-0474-20 18 BLISTER PACK in 1 CARTON
10 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 06/29/2009
NICORETTE WHITE ICE MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
CARNAUBA WAX
D&C YELLOW NO. 10
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE (cream) Score no score
Shape SQUARE Size 15mm
Flavor MINT (White Ice Mint) Imprint Code N4
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0475-01 1 BLISTER PACK in 1 CARTON
1 20 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0475-02 1 BLISTER PACK in 1 CARTON
2 100 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0475-03 1 BLISTER PACK in 1 CARTON
3 190 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0475-05 1 BLISTER PACK in 1 CARTON
4 160 GUM, CHEWING in 1 BLISTER PACK
5 NDC:0135-0475-08 20 GUM, CHEWING in 1 CARTON
6 NDC:0135-0475-14 25 GUM, CHEWING in 1 CARTON
7 NDC:0135-0475-15 8 CARTON in 1 PACKAGE
7 25 GUM, CHEWING in 1 CARTON
8 NDC:0135-0475-17 1 BLISTER PACK in 1 CARTON
8 10 GUM, CHEWING in 1 BLISTER PACK
9 NDC:0135-0475-18 2 CARTON in 1 PACKAGE
9 10 BLISTER PACK in 1 CARTON
9 10 GUM, CHEWING in 1 BLISTER PACK
10 NDC:0135-0475-19 12 BLISTER PACK in 1 CARTON
10 10 GUM, CHEWING in 1 BLISTER PACK
11 NDC:0135-0475-20 18 BLISTER PACK in 1 CARTON
11 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 06/29/2009
NICORETTE ORIGINAL
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
GLYCERIN
SODIUM BICARBONATE
SODIUM CARBONATE
SORBITOL
Product Characteristics
Color WHITE (beige) Score no score
Shape SQUARE Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0157-07 1 BLISTER PACK in 1 CARTON
1 110 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0157-10 1 BLISTER PACK in 1 CARTON
2 170 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0157-11 1 BLISTER PACK in 1 CARTON
3 200 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0157-12 1 BLISTER PACK in 1 CARTON
4 220 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 06/29/2009
NICORETTE ORIGINAL
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
D&C YELLOW NO. 10
GLYCERIN
SODIUM CARBONATE
SORBITOL
Product Characteristics
Color WHITE (beige) Score no score
Shape SQUARE Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0158-07 1 BLISTER PACK in 1 CARTON
1 110 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0158-10 1 BLISTER PACK in 1 CARTON
2 170 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0158-11 1 BLISTER PACK in 1 CARTON
3 200 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0158-12 1 BLISTER PACK in 1 CARTON
4 220 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 06/29/2009
NICORETTE CINNAMON SURGE
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0466
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM BICARBONATE
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE Score no score
Shape SQUARE Size 15mm
Flavor CINNAMON Imprint Code N2
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0466-01 1 BLISTER PACK in 1 CARTON
1 20 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0466-02 1 BLISTER PACK in 1 CARTON
2 100 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0466-03 1 BLISTER PACK in 1 CARTON
3 190 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0466-05 1 BLISTER PACK in 1 CARTON
4 160 GUM, CHEWING in 1 BLISTER PACK
5 NDC:0135-0466-07 1 BLISTER PACK in 1 CARTON
5 40 GUM, CHEWING in 1 BLISTER PACK
6 NDC:0135-0466-08 20 GUM, CHEWING in 1 CARTON
7 NDC:0135-0466-14 25 GUM, CHEWING in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 06/29/2009
NICORETTE CINNAMON SURGE
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
D&C YELLOW NO. 10
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE (cream) Score no score
Shape SQUARE Size 15mm
Flavor CINNAMON Imprint Code N4
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0467-01 1 BLISTER PACK in 1 CARTON
1 20 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0467-02 1 BLISTER PACK in 1 CARTON
2 100 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0467-05 1 BLISTER PACK in 1 CARTON
3 160 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0467-07 1 BLISTER PACK in 1 CARTON
4 40 GUM, CHEWING in 1 BLISTER PACK
5 NDC:0135-0467-08 20 GUM, CHEWING in 1 CARTON
6 NDC:0135-0467-14 25 GUM, CHEWING in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 06/29/2009
NICORETTE FRESH MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0225
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
SODIUM BICARBONATE
SODIUM CARBONATE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE Score no score
Shape SQUARE Size 15mm
Flavor MINT (Fresh Mint) Imprint Code N2
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0225-02 1 BLISTER PACK in 1 CARTON
1 100 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0225-03 1 BLISTER PACK in 1 CARTON
2 190 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0225-08 20 GUM, CHEWING in 1 CARTON
4 NDC:0135-0225-14 25 GUM, CHEWING in 1 CARTON
5 NDC:0135-0225-15 8 CARTON in 1 PACKAGE
5 25 GUM, CHEWING in 1 CARTON
6 NDC:0135-0225-17 2 CARTON in 1 PACKAGE
6 10 BLISTER PACK in 1 CARTON
6 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 06/29/2009
NICORETTE FRESH MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0226
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
D&C YELLOW NO. 10
ALUMINUM OXIDE
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
SODIUM CARBONATE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE (light cream) Score no score
Shape SQUARE Size 15mm
Flavor MINT (Fresh Mint) Imprint Code N4
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0226-02 1 BLISTER PACK in 1 CARTON
1 100 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0226-03 1 BLISTER PACK in 1 CARTON
2 190 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0226-08 20 GUM, CHEWING in 1 CARTON
4 NDC:0135-0226-14 25 GUM, CHEWING in 1 CARTON
5 NDC:0135-0226-15 8 CARTON in 1 PACKAGE
5 25 GUM, CHEWING in 1 CARTON
6 NDC:0135-0226-17 2 CARTON in 1 PACKAGE
6 10 BLISTER PACK in 1 CARTON
6 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 06/29/2009
NICORETTE MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
SODIUM BICARBONATE
SODIUM CARBONATE
XYLITOL
Product Characteristics
Color BROWN (beige) Score no score
Shape SQUARE Size 14mm
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0229-03 1 BLISTER PACK in 1 CARTON
1 50 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0229-04 1 BLISTER PACK in 1 CARTON
2 110 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0229-05 1 BLISTER PACK in 1 CARTON
3 170 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 06/29/2009
NICORETTE MINT
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
D&C YELLOW NO. 10
ALUMINUM OXIDE
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
SODIUM CARBONATE
XYLITOL
Product Characteristics
Color BROWN (beige) Score no score
Shape SQUARE Size 14mm
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0230-03 1 BLISTER PACK in 1 CARTON
1 50 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0230-04 1 BLISTER PACK in 1 CARTON
2 110 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0230-05 1 BLISTER PACK in 1 CARTON
3 170 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 06/29/2009
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0532
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM BICARBONATE
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color WHITE (beige) Score no score
Shape SQUARE Size 15mm
Flavor SPEARMINT Imprint Code N2
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0532-02 10 BLISTER PACK in 1 CARTON
1 10 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0532-03 16 BLISTER PACK in 1 CARTON
2 10 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0532-12 2 CARTON in 1 PACKAGE
3 10 BLISTER PACK in 1 CARTON
3 10 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0532-13 12 BLISTER PACK in 1 CARTON
4 10 GUM, CHEWING in 1 BLISTER PACK
5 NDC:0135-0532-14 18 BLISTER PACK in 1 CARTON
5 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 09/13/2017
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0533
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color YELLOW Score no score
Shape SQUARE Size 15mm
Flavor SPEARMINT Imprint Code N4
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0533-02 10 BLISTER PACK in 1 CARTON
1 10 GUM, CHEWING in 1 BLISTER PACK
2 NDC:0135-0533-12 2 CARTON in 1 PACKAGE
2 10 BLISTER PACK in 1 CARTON
2 10 GUM, CHEWING in 1 BLISTER PACK
3 NDC:0135-0533-13 12 BLISTER PACK in 1 CARTON
3 10 GUM, CHEWING in 1 BLISTER PACK
4 NDC:0135-0533-14 18 BLISTER PACK in 1 CARTON
4 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 09/13/2017
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0355
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
CARNAUBA WAX
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM OXIDE
MENTHOL, UNSPECIFIED FORM
PEPPERMINT OIL
POLYSORBATE 80
SODIUM CARBONATE
SUCRALOSE
TITANIUM DIOXIDE
XYLITOL
Product Characteristics
Color YELLOW Score no score
Shape SQUARE Size 15mm
Flavor SPEARMINT Imprint Code N4
Contains
Packaging
# Item Code Package Description
1 NDC:0135-0355-03 16 BLISTER PACK in 1 CARTON
1 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 09/13/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Frequently asked questions