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Mini 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
Mini Nicotine
Generic name
Nicotine Polacrilex
Dosage form
Lozenge
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Meijer, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
18
Packages
32
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
50

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
207868
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 7, 2019
Sponsor
PLD ACQUISITIONS
Products on application
2
Submissions recorded
1
Products approved under application 207868.
Product Trade name Form Strength Ingredient Status TE Flags
207868-001 NICOTINE POLACRILEX TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter —
207868-002 NICOTINE POLACRILEX TROCHE/LOZENGE NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 207868.
Type No. Action Status Date Review
Original application 1 Approved February 7, 2019 Standard

Review documents

  • 0 · Original application · June 28, 2022

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260812). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260812 HUMAN OTC DRUG · 20251210

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. 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 • 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 • 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 • 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
17856-1241-1 17856-1241 ATLANTIC BIOLOGICALS CORP. 50 POUCH in 1 BOX (17856-1241-1) / 1 LOZENGE in 1 POUCH (17856-1241-2) May 8, 2024
46122-716-15 46122-716 AmerisourceBergen (Good Neighbor Pharmacy) 46122 3 BOTTLE, PLASTIC in 1 BOX (46122-716-15) / 27 LOZENGE in 1 BOTTLE, PLASTIC February 8, 2023
46122-716-16 46122-716 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 BOTTLE, PLASTIC in 1 BOX (46122-716-16) / 27 LOZENGE in 1 BOTTLE, PLASTIC February 8, 2023
46122-716-60 46122-716 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 BOTTLE, PLASTIC in 1 BOX (46122-716-60) / 20 LOZENGE in 1 BOTTLE, PLASTIC February 22, 2023
69842-934-08 69842-934 CVS Pharmacy 4 BOTTLE, PLASTIC in 1 BOX (69842-934-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC June 30, 2020
69842-934-89 69842-934 CVS Pharmacy 7 BOTTLE, PLASTIC in 1 BOX (69842-934-89) / 27 LOZENGE in 1 BOTTLE, PLASTIC June 30, 2020
68016-087-81 68016-087 Chain Drug Consortium, LLC 3 BOTTLE, PLASTIC in 1 BOX (68016-087-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 30, 2019
55910-662-20 55910-662 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-662-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC October 25, 2023
49035-436-08 49035-436 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 4 BOTTLE, PLASTIC in 1 BOX (49035-436-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC January 15, 2021
49035-436-27 49035-436 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, PLASTIC in 1 BOX (49035-436-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC January 15, 2021
83253-264-18 83253-264 HC Jones, Inc. 4 BOTTLE, PLASTIC in 1 BOX (83253-264-18) / 27 LOZENGE in 1 BOTTLE, PLASTIC September 10, 2026
83253-264-27 83253-264 HC Jones, Inc. 27 LOZENGE in 1 BOTTLE, PLASTIC (83253-264-27) April 30, 2023
83253-264-81 83253-264 HC Jones, Inc. 3 BOTTLE, PLASTIC in 1 BOX (83253-264-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 30, 2023
41250-587-07 41250-587 Meijer Distribution Inc 3 CONTAINER in 1 CARTON (41250-587-07) / 27 LOZENGE in 1 CONTAINER (41250-587-09) May 16, 2019
41250-637-07 41250-637 Meijer Distribution Inc 3 CONTAINER in 1 CARTON (41250-637-07) / 27 LOZENGE in 1 CONTAINER (41250-637-09) May 16, 2019
79481-0223-1 79481-0223 Meijer, Inc. 1 CONTAINER in 1 CARTON (79481-0223-1) / 27 LOZENGE in 1 CONTAINER May 9, 2024
79481-0223-2 79481-0223 Meijer, Inc. 3 CONTAINER in 1 CARTON (79481-0223-2) / 27 LOZENGE in 1 CONTAINER May 9, 2024
79481-0301-0 79481-0301 Meijer, Inc. 1 CONTAINER in 1 CARTON (79481-0301-0) / 27 LOZENGE in 1 CONTAINER May 17, 2024
79481-0301-1 79481-0301 Meijer, Inc. 3 CONTAINER in 1 CARTON (79481-0301-1) / 27 LOZENGE in 1 CONTAINER May 20, 2024
79481-0734-2 79481-0734 Meijer, Inc. 3 CONTAINER in 1 CARTON (79481-0734-2) / 27 LOZENGE in 1 CONTAINER (79481-0734-0) July 1, 2025
79481-0957-2 79481-0957 Meijer, Inc. 3 CONTAINER in 1 CARTON (79481-0957-2) / 27 LOZENGE in 1 CONTAINER (79481-0957-0) January 12, 2025
59726-264-27 59726-264 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-264-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC March 15, 2024
59726-264-35 59726-264 P & L Development, LLC 5 BOTTLE, PLASTIC in 1 BOX (59726-264-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC March 15, 2024
11822-0957-2 11822-0957 Rite Aid Corporation 3 CONTAINER in 1 CARTON (11822-0957-2) / 27 LOZENGE in 1 CONTAINER March 22, 2013
0536-1241-27 0536-1241 Rugby Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 BOX (0536-1241-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 31, 2019
0536-1241-81 0536-1241 Rugby Laboratories, Inc. 3 BOTTLE, PLASTIC in 1 BOX (0536-1241-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 31, 2019
79903-128-08 79903-128 WALMART INC. (see also Equate) 4 BOTTLE, PLASTIC in 1 BOX (79903-128-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 1, 2022
79903-128-27 79903-128 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-128-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 1, 2022
0363-2640-08 0363-2640 Walgreens 4 BOTTLE, PLASTIC in 1 BOX (0363-2640-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC September 1, 2019
0363-2640-20 0363-2640 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-2640-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC September 1, 2019
0363-2640-35 0363-2640 Walgreens 5 BOTTLE, PLASTIC in 1 BOX (0363-2640-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC September 1, 2019
0363-2640-81 0363-2640 Walgreens 3 BOTTLE, PLASTIC in 1 BOX (0363-2640-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC September 1, 2019
17856-1241 17856-1241 ATLANTIC BIOLOGICALS CORP. — July 31, 2019
46122-716 46122-716 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 8, 2023
69842-934 69842-934 CVS Pharmacy — June 30, 2020
68016-087 68016-087 Chain Drug Consortium, LLC — April 30, 2019
55910-662 55910-662 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — October 25, 2023
49035-436 49035-436 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — January 15, 2021
83253-264 83253-264 HC Jones, Inc. — April 30, 2023
41250-587 41250-587 Meijer Distribution Inc — May 16, 2019
41250-637 41250-637 Meijer Distribution Inc — May 16, 2019
79481-0223 79481-0223 Meijer, Inc. — May 9, 2024
79481-0301 79481-0301 Meijer, Inc. — May 17, 2024
79481-0734 79481-0734 Meijer, Inc. — July 1, 2025
79481-0957 79481-0957 Meijer, Inc. — January 12, 2025
59726-264 59726-264 P & L Development, LLC — March 15, 2024
11822-0957 11822-0957 Rite Aid Corporation — January 19, 2013
0536-1241 0536-1241 Rugby Laboratories, Inc. — July 31, 2019
79903-128 79903-128 WALMART INC. (see also Equate) — July 1, 2022
0363-2640 0363-2640 Walgreens — September 1, 2019

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 · 10 sections on this page.