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NICORETTE

nicotine polacrilex · Lozenge

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
Generic name
nicotine polacrilex
Dosage form
Lozenge
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
29
Data completeness
83% 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
Lozenge
Route of administration
Oral
Presentations
42

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
022360
Application type
NDA · New Drug Application
Approval date
May 18, 2009
Sponsor
HALEON US HOLDINGS
Products on application
2
Submissions recorded
15
Products approved under application 022360.
Product Trade name Form Strength Ingredient Status TE Flags
022360-001 NICORETTE TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter — RLD
022360-002 NICORETTE TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter — RLD RS

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
8940772 April 30, 2029 001 No February 25, 2015
8940772 April 30, 2029 002 No February 25, 2015
8501164 June 14, 2029 001 No September 5, 2013
8501164 June 14, 2029 002 No September 5, 2013

Approval history

Source: Drugs@FDA
Most recent submissions on application 022360.
Type No. Action Status Date Review
Supplement 19 Manufacturing (CMC) Approved March 17, 2025 N/A
Supplement 18 Manufacturing (CMC) Approved November 21, 2024 N/A
Supplement 17 Labeling Approved April 30, 2024 Standard
Supplement 12 Manufacturing (CMC) Approved March 5, 2021 N/A
Supplement 11 Labeling Approved June 5, 2018 Standard
Supplement 10 Labeling Approved September 30, 2015 Standard
Supplement 9 Labeling Approved April 16, 2015 Standard
Supplement 8 Manufacturing (CMC) Approved February 14, 2014 Standard
Supplement 7 Labeling Approved October 28, 2013 Standard
Supplement 6 Labeling Approved May 23, 2013 Standard
Supplement 5 Approved March 8, 2013 Standard
Supplement 4 Labeling Approved September 18, 2012 Standard
Supplement 2 Labeling Approved December 6, 2011 Unknown
Supplement 1 Manufacturing (CMC) Approved December 21, 2009 N/A
Original application 1 Type 5 - New Formulation or New Manufacturer Approved May 18, 2009 Standard

Review documents

  • 0 · Supplement · March 18, 2025
  • 0 · Supplement · March 18, 2025
  • 0 · Supplement · November 22, 2024
  • 0 · Supplement · November 22, 2024
  • 0 · Supplement · May 2, 2024
  • 0 · Supplement · May 2, 2024
  • 0 · Supplement · June 15, 2021
  • 0 · Supplement · June 15, 2021
  • 0 · Supplement · June 21, 2018
  • 0 · Supplement · June 14, 2018
  • 0 · Supplement · June 28, 2017
  • 0 · Supplement · November 18, 2015
  • 0 · Supplement · October 22, 2015
  • 0 · Supplement · October 2, 2015
  • 0 · Supplement · April 21, 2015
  • 0 · Supplement · April 17, 2015
  • 0 · Supplement · November 7, 2013
  • 0 · Supplement · October 29, 2013
  • 0 · Supplement · September 24, 2013
  • 0 · Supplement · May 28, 2013
  • 0 · Supplement · April 17, 2013
  • 0 · Supplement · September 24, 2012
  • 0 · Supplement · December 8, 2011
  • 0 · Original application · December 30, 2009
  • 0 · Original application · December 30, 2009
  • 0 · Original application · May 27, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250425). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250425 HUMAN OTC DRUG · 20250425 HUMAN OTC DRUG · 20240321

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. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes) • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge 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. Do not use (Mint) if you are allergic to soya 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 your blood pressure. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use (Mint) if you are allergic to soya

Ask a Doctor

openFDA Drug Labeling

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 your blood pressure. • stomach ulcer or diabetes • history of seizures

Stop use and ask a doctor if • mouth problems occur • persistent indigestion or severe sore throat occurs • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each lozenge) (2 mg) Nicotine polacrilex, 2 mg (nicotine)

Active ingredient (in each lozenge) (4 mg) Nicotine polacrilex, 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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III April 30, 2014 GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Terminated
Class III April 30, 2014 GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Terminated
Class III April 30, 2014 GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Terminated
Class III April 30, 2014 GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Terminated

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
0135-0508-02 0135-0508 Haleon US Holdings LLC 3 CONTAINER in 1 CARTON (0135-0508-02) / 27 LOZENGE in 1 CONTAINER March 1, 2010
0135-0508-03 0135-0508 Haleon US Holdings LLC 5 CONTAINER in 1 CARTON (0135-0508-03) / 27 LOZENGE in 1 CONTAINER March 1, 2010
0135-0508-04 0135-0508 Haleon US Holdings LLC 20 LOZENGE in 1 CONTAINER (0135-0508-04) March 1, 2010
0135-0510-01 0135-0510 Haleon US Holdings LLC 3 CONTAINER in 1 CARTON (0135-0510-01) / 24 LOZENGE in 1 CONTAINER October 19, 2010
0135-0510-06 0135-0510 Haleon US Holdings LLC 1 CONTAINER in 1 CARTON (0135-0510-06) / 24 LOZENGE in 1 CONTAINER September 1, 2015
0135-0510-07 0135-0510 Haleon US Holdings LLC 6 CONTAINER in 1 CARTON (0135-0510-07) / 24 LOZENGE in 1 CONTAINER September 1, 2015
0135-0511-01 0135-0511 Haleon US Holdings LLC 3 CONTAINER in 1 CARTON (0135-0511-01) / 24 LOZENGE in 1 CONTAINER October 19, 2010
0135-0511-06 0135-0511 Haleon US Holdings LLC 1 CONTAINER in 1 CARTON (0135-0511-06) / 24 LOZENGE in 1 CONTAINER September 1, 2015
0135-0511-07 0135-0511 Haleon US Holdings LLC 6 CONTAINER in 1 CARTON (0135-0511-07) / 24 LOZENGE in 1 CONTAINER September 1, 2015
0135-0625-01 0135-0625 Haleon US Holdings LLC 1 CONTAINER in 1 CARTON (0135-0625-01) / 20 LOZENGE in 1 CONTAINER April 11, 2019
0135-0625-02 0135-0625 Haleon US Holdings LLC 4 CONTAINER in 1 CARTON (0135-0625-02) / 20 LOZENGE in 1 CONTAINER April 11, 2019
0135-0625-03 0135-0625 Haleon US Holdings LLC 6 CONTAINER in 1 CARTON (0135-0625-03) / 20 LOZENGE in 1 CONTAINER October 23, 2019
0135-0626-01 0135-0626 Haleon US Holdings LLC 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINER April 11, 2019
0135-0626-02 0135-0626 Haleon US Holdings LLC 4 CONTAINER in 1 CARTON (0135-0626-02) / 20 LOZENGE in 1 CONTAINER April 11, 2019
0135-0626-03 0135-0626 Haleon US Holdings LLC 6 CONTAINER in 1 CARTON (0135-0626-03) / 20 LOZENGE in 1 CONTAINER October 23, 2019
0135-0635-01 0135-0635 Haleon US Holdings LLC 3 CONTAINER in 1 CARTON (0135-0635-01) / 72 LOZENGE in 1 CONTAINER June 1, 2022
0135-0636-01 0135-0636 Haleon US Holdings LLC 3 CONTAINER in 1 CARTON (0135-0636-01) / 72 LOZENGE in 1 CONTAINER June 1, 2022
0135-1500-01 0135-1500 Haleon US Holdings LLC 20 LOZENGE in 1 CONTAINER (0135-1500-01) June 1, 2022
0135-1500-02 0135-1500 Haleon US Holdings LLC 3 VIAL in 1 CARTON (0135-1500-02) / 27 LOZENGE in 1 VIAL June 1, 2022
0135-2800-01 0135-2800 Haleon US Holdings LLC 20 LOZENGE in 1 CONTAINER (0135-2800-01) June 1, 2022
0135-2800-02 0135-2800 Haleon US Holdings LLC 3 VIAL in 1 CARTON (0135-2800-02) / 27 LOZENGE in 1 VIAL June 1, 2022
0135-8050-20 0135-8050 Haleon US Holdings LLC 1 VIAL in 1 PACKAGE (0135-8050-20) / 20 LOZENGE in 1 VIAL September 1, 2025
0135-8050-81 0135-8050 Haleon US Holdings LLC 3 VIAL in 1 PACKAGE (0135-8050-81) / 27 LOZENGE in 1 VIAL September 1, 2025
0135-8060-20 0135-8060 Haleon US Holdings LLC 1 VIAL in 1 PACKAGE (0135-8060-20) / 20 LOZENGE in 1 VIAL September 1, 2025
0135-8060-81 0135-8060 Haleon US Holdings LLC 3 VIAL in 1 PACKAGE (0135-8060-81) / 27 LOZENGE in 1 VIAL September 1, 2025
0135-8070-20 0135-8070 Haleon US Holdings LLC 1 VIAL in 1 PACKAGE (0135-8070-20) / 20 LOZENGE in 1 VIAL April 1, 2026
0135-8070-81 0135-8070 Haleon US Holdings LLC 3 VIAL in 1 PACKAGE (0135-8070-81) / 27 LOZENGE in 1 VIAL April 1, 2026
0135-8071-20 0135-8071 Haleon US Holdings LLC 1 VIAL in 1 PACKAGE (0135-8071-20) / 20 LOZENGE in 1 VIAL April 1, 2026
0135-8071-81 0135-8071 Haleon US Holdings LLC 3 VIAL in 1 PACKAGE (0135-8071-81) / 27 LOZENGE in 1 VIAL April 1, 2026
0135-0508 0135-0508 Haleon US Holdings LLC — March 1, 2010
0135-0510 0135-0510 Haleon US Holdings LLC — October 19, 2010
0135-0511 0135-0511 Haleon US Holdings LLC — October 19, 2010
0135-0625 0135-0625 Haleon US Holdings LLC — April 11, 2019
0135-0626 0135-0626 Haleon US Holdings LLC — April 11, 2019
0135-0635 0135-0635 Haleon US Holdings LLC — June 1, 2022
0135-0636 0135-0636 Haleon US Holdings LLC — June 1, 2022
0135-1500 0135-1500 Haleon US Holdings LLC — June 1, 2022
0135-2800 0135-2800 Haleon US Holdings LLC — June 1, 2022
0135-8050 0135-8050 Haleon US Holdings LLC — September 1, 2025
0135-8060 0135-8060 Haleon US Holdings LLC — September 1, 2025
0135-8070 0135-8070 Haleon US Holdings LLC — April 1, 2026
0135-8071 0135-8071 Haleon US Holdings LLC — April 1, 2026

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
Enforcement FDA Recall records

Generated September 25, 2026 · 14 sections on this page.