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NICORETTE
nicotine polacrilex · Lozenge
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cholinergic Nicotinic Agonist [EPC] | EPC | All 61 members |
| Nicotine [CS] | CS | All 61 members |
Regulatory status
Source: Drugs@FDANDC Directory| 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 BookCodes 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 | 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUse • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose
openFDA Drug LabelingPurpose Stop smoking aid
Dosage and Administration
openFDA Drug LabelingDirections (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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo not use (Mint) if you are allergic to soya
Ask a Doctor
openFDA Drug LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive 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 FAERSAttributed 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| 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| 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
| 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.