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Nicorette

nicotine polacrilex · Gum, Chewing

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Nicorette Spearmint Burst
Generic name
nicotine polacrilex
Dosage form
Gum, Chewing
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
13
Packages
61
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Nicotine 2 mg/1 359817 View
Nicotine 4 mg/1 359817 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gum, Chewing
Route of administration
Oral
Presentations
74

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cholinergic Nicotinic Agonist [EPC] EPC All 61 members
Nicotine [CS] CS All 61 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020066
Application type
NDA · New Drug Application
Approval date
June 8, 1992
Sponsor
HALEON US HOLDINGS
Products on application
3
Submissions recorded
38
Products approved under application 020066.
Product Trade name Form Strength Ingredient Status TE Flags
020066-002 NICORETTE GUM, CHEWING NICOTINE POLACRILEX Over-the-counter — RLD RS
020066-003 NICORETTE (MINT) GUM, CHEWING NICOTINE POLACRILEX Over-the-counter — RLD
020066-004 NICORETTE GUM, CHEWING NICOTINE POLACRILEX Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8323683 April 30, 2028 002 No January 3, 2013

Approval history

Source: Drugs@FDA
Most recent submissions on application 020066.
Type No. Action Status Date Review
Supplement 66 Labeling Approved January 3, 2024 Standard
Supplement 65 Labeling Approved April 23, 2021 Standard
Supplement 64 Labeling Approved November 15, 2019 Standard
Supplement 62 Labeling Approved November 14, 2018 Standard
Supplement 61 Labeling Approved June 5, 2018 Standard
Supplement 60 Labeling Approved December 11, 2017 Standard
Supplement 59 Manufacturing (CMC) Approved September 11, 2017 N/A
Supplement 57 Labeling Approved September 30, 2015 Standard
Supplement 55 Labeling Approved October 30, 2014 Standard
Supplement 54 Labeling Approved June 11, 2014 Standard
Supplement 53 Labeling Approved June 11, 2014 Standard
Supplement 51 Manufacturing (CMC) Approved April 17, 2014 Standard
Supplement 49 Labeling Approved October 30, 2013 Standard
Supplement 48 Manufacturing (CMC) Approved August 1, 2012 Standard
Supplement 46 Labeling Approved July 16, 2012 Standard
Supplement 42 Labeling Approved February 15, 2012 Standard
Supplement 41 Labeling Approved February 1, 2012 Standard
Supplement 38 Labeling Approved September 27, 2011 Standard
Supplement 37 Labeling Approved May 17, 2011 Standard
Supplement 32 Manufacturing (CMC) Approved April 21, 2010 N/A
Supplement 33 Efficacy Approved May 6, 2009 Unknown
Supplement 31 Manufacturing (CMC) Approved June 13, 2008 N/A
Supplement 30 Manufacturing (CMC) Approved June 26, 2007 N/A
Supplement 24 Manufacturing (CMC) Approved May 4, 2006 N/A
Supplement 23 Manufacturing (CMC) Approved December 2, 2005 Standard
Supplement 17 Labeling Approved June 23, 2004 Standard
Supplement 19 Manufacturing (CMC) Approved June 18, 2004 Standard
Supplement 16 Manufacturing (CMC) Approved April 23, 2004 Standard
Supplement 14 Manufacturing (CMC) Approved November 15, 2002 Standard
Supplement 13 Labeling Approved August 9, 2002 Standard
Supplement 8 Labeling Approved August 24, 2001 Standard
Supplement 10 Manufacturing (CMC) Approved September 25, 2000 Standard
Supplement 7 Efficacy Approved December 23, 1998 Unknown
Supplement 6 Manufacturing (CMC) Approved November 4, 1998 Standard
Supplement 4 Efficacy Approved February 9, 1996 Standard
Supplement 3 Manufacturing (CMC) Approved March 22, 1993 Standard
Supplement 1 Manufacturing (CMC) Approved March 22, 1993 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved June 8, 1992 Standard

Review documents

  • 0 · Supplement · January 4, 2024
  • 0 · Supplement · January 4, 2024
  • 0 · Supplement · May 13, 2021
  • 0 · Supplement · April 27, 2021
  • 0 · Supplement · November 20, 2019
  • 0 · Supplement · November 20, 2019
  • 0 · Supplement · November 23, 2018
  • 0 · Supplement · November 21, 2018
  • 0 · Supplement · June 21, 2018
  • 0 · Supplement · June 14, 2018
  • 0 · Supplement · December 18, 2017
  • 0 · Supplement · December 18, 2017
  • 0 · Supplement · October 10, 2017
  • 0 · Supplement · November 2, 2015
  • 0 · Supplement · October 2, 2015
  • 0 · Supplement · November 7, 2014
  • 0 · Supplement · November 3, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · June 12, 2014
  • 0 · Supplement · June 12, 2014
  • 0 · Supplement · January 16, 2014
  • 0 · Supplement · November 7, 2013
  • 0 · Supplement · October 31, 2013
  • 0 · Supplement · July 18, 2012
  • 0 · Supplement · March 28, 2012
  • 0 · Supplement · March 27, 2012
  • 0 · Supplement · February 17, 2012
  • 0 · Supplement · February 3, 2012
  • 0 · Supplement · September 29, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240813). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240813 HUMAN OTC DRUG · 20240729

Indications and Usage

openFDA Drug Labeling

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

Purpose Stop smoking aid

Dosage and Administration

openFDA Drug Labeling

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

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.

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)

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine) Nicotine polacrilex (equal to 4 mg nicotine)

Adverse event reports

Source: openFDA FAERS
60,672
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NICOTINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0135-0157-07 0135-0157 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0157-07) / 110 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0157-10 0135-0157 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0157-10) / 170 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0157-11 0135-0157 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0157-11) / 200 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0158-07 0135-0158 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0158-07) / 110 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0158-10 0135-0158 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0158-10) / 170 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0158-11 0135-0158 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0158-11) / 200 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0229-05 0135-0229 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0229-05) / 170 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0230-03 0135-0230 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0230-03) / 50 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0230-05 0135-0230 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0230-05) / 170 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0241-02 0135-0241 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0241-02) / 100 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0241-05 0135-0241 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0241-05) / 160 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0241-06 0135-0241 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0241-06) / 20 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0241-08 0135-0241 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0241-08) September 14, 2009
0135-0241-17 0135-0241 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0241-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK August 1, 2014
0135-0241-18 0135-0241 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0241-18) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0241-19 0135-0241 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0241-19) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0242-02 0135-0242 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0242-02) / 100 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0242-05 0135-0242 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0242-05) / 160 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0242-06 0135-0242 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0242-06) / 20 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0242-08 0135-0242 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0242-08) September 14, 2009
0135-0242-11 0135-0242 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0242-11) / 10 GUM, CHEWING in 1 BLISTER PACK September 14, 2009
0135-0242-17 0135-0242 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0242-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK August 1, 2014
0135-0242-18 0135-0242 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0242-18) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0242-19 0135-0242 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0242-19) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0355-03 0135-0355 Haleon US Holdings LLC 16 BLISTER PACK in 1 CARTON (0135-0355-03) / 10 GUM, CHEWING in 1 BLISTER PACK September 13, 2017
0135-0466-01 0135-0466 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0466-01) / 20 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0466-02 0135-0466 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0466-02) / 100 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0466-03 0135-0466 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0466-03) / 190 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0466-05 0135-0466 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0466-05) / 160 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0466-07 0135-0466 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0466-07) / 40 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0466-08 0135-0466 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0466-08) June 29, 2009
0135-0467-01 0135-0467 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0467-01) / 20 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0467-02 0135-0467 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0467-02) / 100 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0467-05 0135-0467 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0467-05) / 160 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0467-07 0135-0467 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0467-07) / 40 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0467-08 0135-0467 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0467-08) June 29, 2009
0135-0474-01 0135-0474 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0474-01) / 20 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0474-02 0135-0474 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0474-02) / 100 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0474-05 0135-0474 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0474-05) / 160 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0474-08 0135-0474 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0474-08) June 29, 2009
0135-0474-17 0135-0474 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0474-17) / 10 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0474-18 0135-0474 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0474-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK August 1, 2014
0135-0474-19 0135-0474 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0474-19) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0474-20 0135-0474 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0474-20) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0475-01 0135-0475 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0475-01) / 20 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0475-02 0135-0475 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0475-02) / 100 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0475-05 0135-0475 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0475-05) / 160 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0475-08 0135-0475 Haleon US Holdings LLC 20 GUM, CHEWING in 1 CARTON (0135-0475-08) June 29, 2009
0135-0475-17 0135-0475 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0135-0475-17) / 10 GUM, CHEWING in 1 BLISTER PACK June 29, 2009
0135-0475-18 0135-0475 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0475-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK August 1, 2014
0135-0475-19 0135-0475 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0475-19) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0475-20 0135-0475 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0475-20) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0532-02 0135-0532 Haleon US Holdings LLC 10 BLISTER PACK in 1 CARTON (0135-0532-02) / 10 GUM, CHEWING in 1 BLISTER PACK September 13, 2017
0135-0532-03 0135-0532 Haleon US Holdings LLC 16 BLISTER PACK in 1 CARTON (0135-0532-03) / 10 GUM, CHEWING in 1 BLISTER PACK September 13, 2017
0135-0532-12 0135-0532 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0532-12) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK March 1, 2018
0135-0532-13 0135-0532 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0532-13) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0532-14 0135-0532 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0532-14) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0533-02 0135-0533 Haleon US Holdings LLC 10 BLISTER PACK in 1 CARTON (0135-0533-02) / 10 GUM, CHEWING in 1 BLISTER PACK September 13, 2017
0135-0533-12 0135-0533 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0135-0533-12) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK March 1, 2018
0135-0533-13 0135-0533 Haleon US Holdings LLC 12 BLISTER PACK in 1 CARTON (0135-0533-13) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2018
0135-0533-14 0135-0533 Haleon US Holdings LLC 18 BLISTER PACK in 1 CARTON (0135-0533-14) / 10 GUM, CHEWING in 1 BLISTER PACK December 3, 2018
0135-0157 0135-0157 Haleon US Holdings LLC — June 29, 2009
0135-0158 0135-0158 Haleon US Holdings LLC — June 29, 2009
0135-0229 0135-0229 Haleon US Holdings LLC — June 29, 2009
0135-0230 0135-0230 Haleon US Holdings LLC — June 29, 2009
0135-0241 0135-0241 Haleon US Holdings LLC — September 14, 2009
0135-0242 0135-0242 Haleon US Holdings LLC — September 14, 2009
0135-0355 0135-0355 Haleon US Holdings LLC — September 13, 2017
0135-0466 0135-0466 Haleon US Holdings LLC — June 29, 2009
0135-0467 0135-0467 Haleon US Holdings LLC — June 29, 2009
0135-0474 0135-0474 Haleon US Holdings LLC — June 29, 2009
0135-0475 0135-0475 Haleon US Holdings LLC — June 29, 2009
0135-0532 0135-0532 Haleon US Holdings LLC — September 13, 2017
0135-0533 0135-0533 Haleon US Holdings LLC — September 13, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 13 sections on this page.