DailyMed - NICORETTE WHITE ICE MINT- nicotine polacrilex gum, chewing NICORETTE ORIGINAL- nicotine polacrilex gum, chewing NICORETTE CINNAMON SURGE- nicotine polacrilex gum, chewing NICORETTE FRESH MINT- nicotine polacrilex gum, chewing NICORETTE MINT- nicotine polacrilex gum, chewing NICORETTE SPEARMINT BURST- nicotine polacrilex gum, chewing

NDC Code(s): 0135-0157-07, 0135-0157-10, 0135-0157-11, 0135-0157-12, view more
0135-0158-07, 0135-0158-10, 0135-0158-11, 0135-0158-12, 0135-0225-02, 0135-0225-03, 0135-0225-08, 0135-0225-14, 0135-0225-15, 0135-0225-17, 0135-0226-02, 0135-0226-03, 0135-0226-08, 0135-0226-14, 0135-0226-15, 0135-0226-17, 0135-0229-03, 0135-0229-04, 0135-0229-05, 0135-0230-03, 0135-0230-04, 0135-0230-05, 0135-0355-03, 0135-0466-01, 0135-0466-02, 0135-0466-03, 0135-0466-05, 0135-0466-07, 0135-0466-08, 0135-0466-14, 0135-0467-01, 0135-0467-02, 0135-0467-05, 0135-0467-07, 0135-0467-08, 0135-0467-14, 0135-0474-01, 0135-0474-02, 0135-0474-05, 0135-0474-08, 0135-0474-14, 0135-0474-15, 0135-0474-17, 0135-0474-18, 0135-0474-19, 0135-0474-20, 0135-0475-01, 0135-0475-02, 0135-0475-03, 0135-0475-05, 0135-0475-08, 0135-0475-14, 0135-0475-15, 0135-0475-17, 0135-0475-18, 0135-0475-19, 0135-0475-20, 0135-0532-02, 0135-0532-03, 0135-0532-12, 0135-0532-13, 0135-0532-14, 0135-0533-02, 0135-0533-12, 0135-0533-13, 0135-0533-14
Packager: Haleon US Holdings LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated March 20, 2024

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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

GSKConsumer Healthcare

Warren, NJ 07059

Made in Sweden

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.comor 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 WITHIN30 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 THAN30 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 WITHIN30 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 THAN30 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 WITHIN30 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 THAN30 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 Mint TM

2 mg

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

If you smoke your first cigarette WITHIN30 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 Mint TM

4 mg

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

If you smoke your first cigarette MORE THAN30 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 WITHIN30 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 THAN30 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 mg• stop smoking aid

Gum

NEW FLAVOR

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

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

If you smoke your first cigarette WITHIN30 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 mg• stop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

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

If you smoke your first cigarette MORE THAN30 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 mg• stop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

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

If you smoke your first cigarette MORE THAN30 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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	SQUARE	Size	15mm
Flavor	MINT (White Ice Mint)	Imprint Code	N2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0474-01	1 in 1 CARTON	06/29/2009
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0474-02	1 in 1 CARTON	06/29/2009
2		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0474-05	1 in 1 CARTON	06/29/2009
3		160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0474-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009
5	NDC:0135-0474-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018
6	NDC:0135-0474-15	8 in 1 PACKAGE	06/29/2009	08/01/2018
6		25 in 1 CARTON; Type 0: Not a Combination Product
7	NDC:0135-0474-17	1 in 1 CARTON	06/29/2009
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:0135-0474-18	2 in 1 PACKAGE	08/01/2014
8		10 in 1 CARTON
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:0135-0474-19	12 in 1 CARTON	09/01/2018
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:0135-0474-20	18 in 1 CARTON	12/03/2018
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (cream)	Score	no score
Shape	SQUARE	Size	15mm
Flavor	MINT (White Ice Mint)	Imprint Code	N4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0475-01	1 in 1 CARTON	06/29/2009
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0475-02	1 in 1 CARTON	06/29/2009
2		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0475-03	1 in 1 CARTON	06/29/2009	08/01/2019
3		190 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0475-05	1 in 1 CARTON	06/29/2009
4		160 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0135-0475-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009
6	NDC:0135-0475-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018
7	NDC:0135-0475-15	8 in 1 PACKAGE	06/29/2009	08/01/2018
7		25 in 1 CARTON; Type 0: Not a Combination Product
8	NDC:0135-0475-17	1 in 1 CARTON	06/29/2009
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:0135-0475-18	2 in 1 PACKAGE	08/01/2014
9		10 in 1 CARTON
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:0135-0475-19	12 in 1 CARTON	09/01/2018
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC:0135-0475-20	18 in 1 CARTON	12/03/2018
11		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (beige)	Score	no score
Shape	SQUARE	Size	14mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0157-07	1 in 1 CARTON	06/29/2009
1		110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0157-10	1 in 1 CARTON	06/29/2009
2		170 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0157-11	1 in 1 CARTON	06/29/2009
3		200 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0157-12	1 in 1 CARTON	06/29/2009	08/01/2019
4		220 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (beige)	Score	no score
Shape	SQUARE	Size	14mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0158-07	1 in 1 CARTON	06/29/2009
1		110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0158-10	1 in 1 CARTON	06/29/2009
2		170 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0158-11	1 in 1 CARTON	06/29/2009
3		200 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0158-12	1 in 1 CARTON	06/29/2009	08/01/2019
4		220 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	SQUARE	Size	15mm
Flavor	CINNAMON	Imprint Code	N2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0466-01	1 in 1 CARTON	06/29/2009
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0466-02	1 in 1 CARTON	06/29/2009
2		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0466-03	1 in 1 CARTON	06/29/2009
3		190 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0466-05	1 in 1 CARTON	06/29/2009
4		160 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0135-0466-07	1 in 1 CARTON	06/29/2009
5		40 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:0135-0466-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009
7	NDC:0135-0466-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (cream)	Score	no score
Shape	SQUARE	Size	15mm
Flavor	CINNAMON	Imprint Code	N4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0467-01	1 in 1 CARTON	06/29/2009
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0467-02	1 in 1 CARTON	06/29/2009
2		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0467-05	1 in 1 CARTON	06/29/2009
3		160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0467-07	1 in 1 CARTON	06/29/2009
4		40 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0135-0467-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009
6	NDC:0135-0467-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	SQUARE	Size	15mm
Flavor	MINT (Fresh Mint)	Imprint Code	N2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0225-02	1 in 1 CARTON	06/29/2009
1		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0225-03	1 in 1 CARTON	06/29/2009	08/01/2019
2		190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0225-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2019
4	NDC:0135-0225-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018
5	NDC:0135-0225-15	8 in 1 PACKAGE	06/29/2009	08/01/2018
5		25 in 1 CARTON; Type 0: Not a Combination Product
6	NDC:0135-0225-17	2 in 1 PACKAGE	08/01/2014
6		10 in 1 CARTON
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CARBONATE (UNII: 45P3261C7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (light cream)	Score	no score
Shape	SQUARE	Size	15mm
Flavor	MINT (Fresh Mint)	Imprint Code	N4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0226-02	1 in 1 CARTON	06/29/2009
1		100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0226-03	1 in 1 CARTON	06/29/2009	08/01/2019
2		190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0226-08	20 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2019
4	NDC:0135-0226-14	25 in 1 CARTON; Type 0: Not a Combination Product	06/29/2009	08/01/2018
5	NDC:0135-0226-15	8 in 1 PACKAGE	06/29/2009	08/01/2018
5		25 in 1 CARTON; Type 0: Not a Combination Product
6	NDC:0135-0226-17	2 in 1 PACKAGE	08/01/2014
6		10 in 1 CARTON
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	brown (beige)	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0229-03	1 in 1 CARTON	06/29/2009	08/01/2019
1		50 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0229-04	1 in 1 CARTON	06/29/2009	08/01/2019
2		110 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0229-05	1 in 1 CARTON	06/29/2009
3		170 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	brown (beige)	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0230-03	1 in 1 CARTON	06/29/2009
1		50 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0230-04	1 in 1 CARTON	06/29/2009	08/01/2019
2		110 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0230-05	1 in 1 CARTON	06/29/2009
3		170 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (beige)	Score	no score
Shape	SQUARE	Size	15mm
Flavor	SPEARMINT	Imprint Code	N2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0532-02	10 in 1 CARTON	09/13/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0532-03	16 in 1 CARTON	09/13/2017
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0532-12	2 in 1 PACKAGE	03/01/2018
3		10 in 1 CARTON
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0532-13	12 in 1 CARTON	09/01/2018
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:0135-0532-14	18 in 1 CARTON	12/03/2018
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	yellow	Score	no score
Shape	SQUARE	Size	15mm
Flavor	SPEARMINT	Imprint Code	N4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0533-02	10 in 1 CARTON	09/13/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0135-0533-12	2 in 1 PACKAGE	03/01/2018
2		10 in 1 CARTON
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0135-0533-13	12 in 1 CARTON	09/01/2018
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0135-0533-14	18 in 1 CARTON	12/03/2018
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	yellow	Score	no score
Shape	SQUARE	Size	15mm
Flavor	SPEARMINT	Imprint Code	N4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0355-03	16 in 1 CARTON	09/13/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020066	09/13/2017

Labeler - Haleon US Holdings LLC (079944263)

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Published Date (What is this?)	Version	Files
Mar 22, 2024	25 (current)	download
Oct 9, 2023	24	download
Jan 23, 2023	23	download
Nov 17, 2020	22	download
Nov 28, 2018	21	download
Aug 7, 2018	20	download
Jun 29, 2018	19	download
Mar 2, 2018	18	download
Sep 13, 2017	17	download
Dec 20, 2016	15	download
Dec 7, 2015	14	download
Nov 21, 2014	13	download
Jun 27, 2014	12	download
Jun 2, 2014	11	download
Feb 6, 2013	10	download
Jan 18, 2012	9	download
Nov 17, 2011	8	download
Nov 7, 2011	7	download
Jul 8, 2011	6	download
Feb 23, 2011	5	download
Jul 9, 2010	4	download
Oct 9, 2009	3	download
Sep 17, 2009	2	download
Jul 17, 2009	1	download

	RxCUI	RxNorm NAME	RxTTY
1	105071	Nicorette 4 MG Chewing Gum	PSN
2	105071	nicotine 4 MG Chewing Gum [Nicorette]	SBD
3	105071	Nicorette 4 MG Chewing Gum	SY
4	209326	Nicorette 2 MG Chewing Gum	PSN
5	209326	nicotine 2 MG Chewing Gum [Nicorette]	SBD
6	209326	Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY
7	209326	Nicorette 2 MG Chewing Gum	SY
8	311975	nicotine polacrilex 4 MG Chewing Gum	PSN
9	311975	nicotine 4 MG Chewing Gum	SCD
10	311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY
11	314119	nicotine polacrilex 2 MG Chewing Gum	PSN
12	314119	nicotine 2 MG Chewing Gum	SCD
13	314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY

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Drug Label Information

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

Ask a doctor before use if you have

Ask a doctor or a pharmacist before use if you are

Stop use and ask a doctor if

Keep out of reach of children and pets.

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Safety

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More Info on this Drug

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

	NDC
1	0135-0157-07
2	0135-0157-10
3	0135-0157-11
4	0135-0157-12
5	0135-0158-07
6	0135-0158-10
7	0135-0158-11
8	0135-0158-12
9	0135-0225-02
10	0135-0225-03
11	0135-0225-08
12	0135-0225-14
13	0135-0225-15
14	0135-0225-17
15	0135-0226-02
16	0135-0226-03
17	0135-0226-08
18	0135-0226-14
19	0135-0226-15
20	0135-0226-17
21	0135-0229-03
22	0135-0229-04
23	0135-0229-05
24	0135-0230-03
25	0135-0230-04
26	0135-0230-05
27	0135-0355-03
28	0135-0466-01
29	0135-0466-02
30	0135-0466-03
31	0135-0466-05
32	0135-0466-07
33	0135-0466-08
34	0135-0466-14
35	0135-0467-01
36	0135-0467-02
37	0135-0467-05
38	0135-0467-07
39	0135-0467-08
40	0135-0467-14
41	0135-0474-01
42	0135-0474-02
43	0135-0474-05
44	0135-0474-08
45	0135-0474-14
46	0135-0474-15
47	0135-0474-17
48	0135-0474-18
49	0135-0474-19
50	0135-0474-20
51	0135-0475-01
52	0135-0475-02
53	0135-0475-03
54	0135-0475-05
55	0135-0475-08
56	0135-0475-14
57	0135-0475-15
58	0135-0475-17
59	0135-0475-18
60	0135-0475-19
61	0135-0475-20
62	0135-0532-02
63	0135-0532-03
64	0135-0532-12
65	0135-0532-13
66	0135-0532-14
67	0135-0533-02
68	0135-0533-12
69	0135-0533-13
70	0135-0533-14

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

Ask a doctor before use if you have

Ask a doctor or a pharmacist before use if you are

Stop use and ask a doctor if

Keep out of reach of children and pets.

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Number of versions: 24

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