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Nicotine Mini

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
Nicotine Mini
Generic name
nicotine polacrilex
Dosage form
Lozenge
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Amazon.com Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
26
Packages
47
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
73

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 20260716). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260716 HUMAN OTC DRUG · 20260624 HUMAN OTC DRUG · 20260212

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
17856-1239-1 17856-1239 ATLANTIC BIOLOGICALS CORP. 50 POUCH in 1 BOX, UNIT-DOSE (17856-1239-1) / 1 LOZENGE in 1 POUCH (17856-1239-2) May 8, 2024
72888-186-53 72888-186 Advagen Pharma Limited 1 BOTTLE in 1 CARTON (72888-186-53) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-186-54 72888-186 Advagen Pharma Limited 3 BOTTLE in 1 CARTON (72888-186-54) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-186-55 72888-186 Advagen Pharma Limited 4 BOTTLE in 1 CARTON (72888-186-55) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-186-56 72888-186 Advagen Pharma Limited 5 BOTTLE in 1 CARTON (72888-186-56) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-187-53 72888-187 Advagen Pharma Limited 1 BOTTLE in 1 CARTON (72888-187-53) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-187-54 72888-187 Advagen Pharma Limited 3 BOTTLE in 1 CARTON (72888-187-54) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-187-55 72888-187 Advagen Pharma Limited 4 BOTTLE in 1 CARTON (72888-187-55) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72888-187-56 72888-187 Advagen Pharma Limited 5 BOTTLE in 1 CARTON (72888-187-56) / 27 LOZENGE in 1 BOTTLE April 14, 2023
72288-375-01 72288-375 Amazon.com Services LLC 1 CONTAINER in 1 CARTON (72288-375-01) / 27 LOZENGE in 1 CONTAINER (72288-375-27) July 9, 2026
72288-375-07 72288-375 Amazon.com Services LLC 8 CONTAINER in 1 CARTON (72288-375-07) / 27 LOZENGE in 1 CONTAINER (72288-375-27) July 2, 2026
72288-569-01 72288-569 Amazon.com Services LLC 1 CONTAINER in 1 CARTON (72288-569-01) / 27 LOZENGE in 1 CONTAINER (72288-569-27) August 5, 2026
72288-569-04 72288-569 Amazon.com Services LLC 5 CONTAINER in 1 CARTON (72288-569-04) / 27 LOZENGE in 1 CONTAINER (72288-569-27) June 18, 2026
72288-569-07 72288-569 Amazon.com Services LLC 8 CONTAINER in 1 CARTON (72288-569-07) / 27 LOZENGE in 1 CONTAINER (72288-569-27) August 27, 2026
72288-739-14 72288-739 Amazon.com Services LLC 5 CONTAINER in 1 CARTON (72288-739-14) / 27 LOZENGE in 1 CONTAINER (72288-739-27) August 20, 2026
72288-797-14 72288-797 Amazon.com Services LLC 5 CONTAINER in 1 CARTON (72288-797-14) / 27 LOZENGE in 1 CONTAINER (72288-797-27) July 9, 2026
46122-715-60 46122-715 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 BOTTLE, PLASTIC in 1 BOX (46122-715-60) / 20 LOZENGE in 1 BOTTLE, PLASTIC February 6, 2023
46122-731-15 46122-731 AmerisourceBergen (Good Neighbor Pharmacy) 46122 3 BOTTLE, PLASTIC in 1 BOX (46122-731-15) / 27 LOZENGE in 1 BOTTLE, PLASTIC February 21, 2023
46122-731-16 46122-731 AmerisourceBergen (Good Neighbor Pharmacy) 46122 1 BOTTLE, PLASTIC in 1 BOX (46122-731-16) / 27 LOZENGE in 1 BOTTLE, PLASTIC February 21, 2023
69842-964-08 69842-964 CVS Pharmacy 4 BOTTLE, PLASTIC in 1 BOX (69842-964-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC June 30, 2020
69842-976-08 69842-976 CVS Pharmacy 4 BOTTLE, PLASTIC in 1 BOX (69842-976-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 31, 2020
70000-0559-1 70000-0559 Cardinal Health (Leader) 70000 3 BOTTLE, PLASTIC in 1 BOX (70000-0559-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 24, 2020
70000-0560-1 70000-0560 Cardinal Health (Leader) 70000 3 BOTTLE, PLASTIC in 1 BOX (70000-0560-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC December 27, 2019
49035-493-08 49035-493 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 4 BOTTLE, PLASTIC in 1 BOX (49035-493-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC January 15, 2021
49035-493-27 49035-493 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, PLASTIC in 1 BOX (49035-493-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC January 15, 2021
83253-262-18 83253-262 HC Jones, Inc. 4 BOTTLE, PLASTIC in 1 BOX (83253-262-18) / 27 LOZENGE in 1 BOTTLE, PLASTIC September 10, 2026
83253-262-27 83253-262 HC Jones, Inc. 27 LOZENGE in 1 BOTTLE, PLASTIC (83253-262-27) April 30, 2023
83253-262-81 83253-262 HC Jones, Inc. 3 BOTTLE, PLASTIC in 1 BOTTLE (83253-262-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 30, 2023
30142-060-02 30142-060 Kroger Company 3 CONTAINER in 1 CARTON (30142-060-02) / 27 LOZENGE in 1 CONTAINER (30142-060-01) February 12, 2016
30142-209-02 30142-209 Kroger Company 3 CONTAINER in 1 CARTON (30142-209-02) / 27 LOZENGE in 1 CONTAINER (30142-209-01) April 19, 2016
59726-262-27 59726-262 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-262-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 1, 2019
59726-262-35 59726-262 P & L Development, LLC 5 BOTTLE, PLASTIC in 1 BOX (59726-262-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC April 1, 2019
59726-652-04 59726-652 P & L Development, LLC 5 BOTTLE, PLASTIC in 1 BOX (59726-652-04) / 27 LOZENGE in 1 BOTTLE, PLASTIC June 1, 2025
59726-652-27 59726-652 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-652-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC June 1, 2025
11822-3315-1 11822-3315 Rite Aid Corporation 3 BOTTLE, PLASTIC in 1 BOX (11822-3315-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC December 27, 2019
0536-1239-27 0536-1239 Rugby Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 BOX (0536-1239-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 31, 2019
0536-1239-81 0536-1239 Rugby Laboratories, Inc. 3 BOTTLE, PLASTIC in 1 BOX (0536-1239-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 31, 2019
79903-127-08 79903-127 WALMART INC. (see also Equate) 4 BOTTLE, PLASTIC in 1 BOX (79903-127-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 1, 2022
79903-127-27 79903-127 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-127-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC July 1, 2022
0363-1130-07 0363-1130 Walgreen Company 3 CONTAINER in 1 CARTON (0363-1130-07) / 27 LOZENGE in 1 CONTAINER (0363-1130-09) November 20, 2018
0363-1130-60 0363-1130 Walgreen Company 1 CONTAINER in 1 CARTON (0363-1130-60) / 20 LOZENGE in 1 CONTAINER November 20, 2018
0363-6011-07 0363-6011 Walgreen Company 3 BOTTLE in 1 CARTON (0363-6011-07) / 27 LOZENGE in 1 BOTTLE (0363-6011-09) August 19, 2024
0363-7051-07 0363-7051 Walgreen Company 3 CONTAINER in 1 CARTON (0363-7051-07) / 27 LOZENGE in 1 CONTAINER (0363-7051-09) July 12, 2024
0363-0262-08 0363-0262 Walgreens 4 BOTTLE, PLASTIC in 1 BOX (0363-0262-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC August 30, 2019
0363-0262-20 0363-0262 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0262-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC August 30, 2019
0363-0262-35 0363-0262 Walgreens 5 BOTTLE, PLASTIC in 1 BOX (0363-0262-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC August 30, 2019
0363-0262-81 0363-0262 Walgreens 3 BOTTLE, PLASTIC in 1 BOTTLE (0363-0262-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC August 30, 2019
17856-1239 17856-1239 ATLANTIC BIOLOGICALS CORP. — July 31, 2019
72888-186 72888-186 Advagen Pharma Limited — April 14, 2023
72888-187 72888-187 Advagen Pharma Limited — April 14, 2023
72288-375 72288-375 Amazon.com Services LLC — July 2, 2026
72288-569 72288-569 Amazon.com Services LLC — June 18, 2026
72288-739 72288-739 Amazon.com Services LLC — August 20, 2026
72288-797 72288-797 Amazon.com Services LLC — July 9, 2026
46122-715 46122-715 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 6, 2023
46122-731 46122-731 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 21, 2023
69842-964 69842-964 CVS Pharmacy — June 30, 2020
69842-976 69842-976 CVS Pharmacy — July 31, 2020
70000-0559 70000-0559 Cardinal Health (Leader) 70000 — April 24, 2020
70000-0560 70000-0560 Cardinal Health (Leader) 70000 — December 27, 2019
49035-493 49035-493 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — January 15, 2021
83253-262 83253-262 HC Jones, Inc. — April 30, 2023
30142-060 30142-060 Kroger Company — February 12, 2016
30142-209 30142-209 Kroger Company — April 19, 2016
59726-262 59726-262 P & L Development, LLC — April 1, 2019
59726-652 59726-652 P & L Development, LLC — June 1, 2025
11822-3315 11822-3315 Rite Aid Corporation — December 27, 2019
0536-1239 0536-1239 Rugby Laboratories, Inc. — July 31, 2019
79903-127 79903-127 WALMART INC. (see also Equate) — July 1, 2022
0363-1130 0363-1130 Walgreen Company — November 20, 2018
0363-6011 0363-6011 Walgreen Company — August 19, 2024
0363-7051 0363-7051 Walgreen Company — July 12, 2024
0363-0262 0363-0262 Walgreens — August 30, 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.