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equate nicotine

Nicotine Polacrilex · Lozenge

Over-the-counter ANDA 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
equate nicotine
Generic name
Nicotine Polacrilex
Dosage form
Lozenge
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Wal-Mart Stores Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
14
Packages
26
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
Lozenge
Route of administration
Oral
Presentations
40

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
203690
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 9, 2012
Sponsor
PPI-DAC
Products on application
2
Submissions recorded
8
Products approved under application 203690.
Product Trade name Form Strength Ingredient Status TE Flags
203690-001 NICOTINE POLACRILEX TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter —
203690-002 NICOTINE POLACRILEX TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 203690.
Type No. Action Status Date Review
Supplement 22 Manufacturing (CMC) Approved December 27, 2019 —
Supplement 18 Manufacturing (CMC) Approved November 1, 2018 —
Supplement 17 Manufacturing (CMC) Approved November 1, 2018 Unknown
Supplement 10 Labeling Approved January 14, 2016 Standard
Supplement 7 Labeling Approved January 14, 2016 Standard
Supplement 4 Labeling Approved January 14, 2016 Standard
Supplement 3 Manufacturing (CMC) Approved June 30, 2014 Unknown
Original application 1 Approved October 9, 2012 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260715). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260715 HUMAN OTC DRUG · 20260416 HUMAN OTC DRUG · 20260120 HUMAN OTC DRUG · 20221206

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 • 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.

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 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. (1-800-222-1222)

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) Nicotine polacrilex, 2 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
79903-104-08 79903-104 WALMART INC. 4 CONTAINER in 1 CARTON (79903-104-08) / 27 LOZENGE in 1 CONTAINER May 11, 2022
79903-104-27 79903-104 WALMART INC. 1 CONTAINER in 1 CARTON (79903-104-27) / 27 LOZENGE in 1 CONTAINER May 11, 2022
79903-160-08 79903-160 WALMART INC. 4 CONTAINER in 1 CARTON (79903-160-08) / 27 LOZENGE in 1 CONTAINER May 11, 2022
79903-160-27 79903-160 WALMART INC. 1 CONTAINER in 1 CARTON (79903-160-27) / 27 LOZENGE in 1 CONTAINER May 11, 2022
79903-182-20 79903-182 WALMART INC. 1 CONTAINER in 1 CARTON (79903-182-20) / 20 LOZENGE in 1 CONTAINER June 15, 2023
79903-182-80 79903-182 WALMART INC. 2 CONTAINER in 1 CARTON (79903-182-80) / 40 LOZENGE in 1 CONTAINER (79903-182-40) June 7, 2023
79903-353-20 79903-353 WALMART INC. 1 CONTAINER in 1 CARTON (79903-353-20) / 20 LOZENGE in 1 CONTAINER July 13, 2026
79903-353-80 79903-353 WALMART INC. 2 CONTAINER in 1 CARTON (79903-353-80) / 40 LOZENGE in 1 CONTAINER (79903-353-40) July 13, 2026
79903-354-20 79903-354 WALMART INC. 1 CONTAINER in 1 CARTON (79903-354-20) / 20 LOZENGE in 1 CONTAINER September 11, 2026
79903-354-80 79903-354 WALMART INC. 2 CONTAINER in 1 CARTON (79903-354-80) / 40 LOZENGE in 1 CONTAINER (79903-354-40) September 11, 2026
49035-124-09 49035-124 Wal-Mart Stores Inc 27 LOZENGE in 1 CONTAINER (49035-124-09) September 10, 2009
49035-124-10 49035-124 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-124-10) / 27 LOZENGE in 1 CONTAINER September 10, 2009
49035-190-09 49035-190 Wal-Mart Stores Inc 27 LOZENGE in 1 CONTAINER (49035-190-09) September 10, 2009
49035-190-10 49035-190 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-190-10) / 27 LOZENGE in 1 CONTAINER September 10, 2009
49035-201-09 49035-201 Wal-Mart Stores Inc 27 LOZENGE in 1 CONTAINER (49035-201-09) October 11, 2016
49035-201-10 49035-201 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-201-10) / 27 LOZENGE in 1 CONTAINER October 11, 2016
49035-702-10 49035-702 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-702-10) / 27 LOZENGE in 1 CONTAINER (49035-702-09) October 7, 2016
49035-734-01 49035-734 Wal-Mart Stores Inc 1 CONTAINER in 1 CARTON (49035-734-01) / 27 LOZENGE in 1 CONTAINER February 14, 2013
49035-791-10 49035-791 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-791-10) / 27 LOZENGE in 1 CONTAINER (49035-791-09) April 1, 2019
49035-873-03 49035-873 Wal-Mart Stores Inc 1 CONTAINER in 1 CARTON (49035-873-03) / 24 LOZENGE in 1 CONTAINER October 10, 2011
49035-873-10 49035-873 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-873-10) / 27 LOZENGE in 1 CONTAINER May 25, 2010
49035-873-11 49035-873 Wal-Mart Stores Inc 7 CONTAINER in 1 CARTON (49035-873-11) / 24 LOZENGE in 1 CONTAINER February 27, 2020
49035-900-10 49035-900 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-900-10) / 27 LOZENGE in 1 CONTAINER (49035-900-09) April 1, 2019
49035-998-03 49035-998 Wal-Mart Stores Inc 1 CONTAINER in 1 CARTON (49035-998-03) / 24 LOZENGE in 1 CONTAINER October 7, 2011
49035-998-10 49035-998 Wal-Mart Stores Inc 4 CONTAINER in 1 CARTON (49035-998-10) / 27 LOZENGE in 1 CONTAINER (49035-998-09) March 24, 2010
49035-998-11 49035-998 Wal-Mart Stores Inc 7 CONTAINER in 1 CARTON (49035-998-11) / 24 LOZENGE in 1 CONTAINER April 17, 2020
79903-104 79903-104 WALMART INC. — May 11, 2022
79903-160 79903-160 WALMART INC. — May 11, 2022
79903-182 79903-182 WALMART INC. — June 7, 2023
79903-353 79903-353 WALMART INC. — July 13, 2026
79903-354 79903-354 WALMART INC. — September 11, 2026
49035-124 49035-124 Wal-Mart Stores Inc — September 10, 2009
49035-190 49035-190 Wal-Mart Stores Inc — September 10, 2009
49035-201 49035-201 Wal-Mart Stores Inc — October 11, 2016
49035-702 49035-702 Wal-Mart Stores Inc — October 7, 2016
49035-734 49035-734 Wal-Mart Stores Inc — February 14, 2013
49035-791 49035-791 Wal-Mart Stores Inc — April 1, 2019
49035-873 49035-873 Wal-Mart Stores Inc — December 15, 2006
49035-900 49035-900 Wal-Mart Stores Inc — April 1, 2019
49035-998 49035-998 Wal-Mart Stores Inc — December 15, 2006

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
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.