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Nicotine Polacrilex

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 Polacrilex
Generic name
Nicotine Polacrilex
Dosage form
Gum, Chewing
Route
—
Marketing category
ANDA · ANDA
Labeler
Fertin Pharma A/S
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
95
Packages
129
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
Gum, Chewing
Route of administration
—
Presentations
224

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
078697
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 29, 2008
Sponsor
P AND L
Products on application
1
Submissions recorded
4
Products approved under application 078697.
Product Trade name Form Strength Ingredient Status TE Flags
078697-001 NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 078697.
Type No. Action Status Date Review
Supplement 15 Labeling Approved April 14, 2017 Standard
Supplement 11 Labeling Approved April 30, 2015 Standard
Supplement 9 Labeling Approved January 28, 2013 Standard
Original application 1 Approved December 29, 2008 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260519). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260519 HUMAN OTC DRUG · 20260508 HUMAN OTC DRUG · 20260318 HUMAN OTC DRUG · 20250718

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 before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum 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 before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day. if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum 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

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 blood pressure. stomach ulcer or diabetes history of seizures

Stop use and ask a doctor if mouth, teeth, or jaw problems occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat oral blistering occurs you get symptoms of an allergic reaction (such as difficulty breathing or rash)

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each chewing piece) - 2 mg Nicotine polacrilex (equal to 2 mg nicotine)

Active ingredient (in each chewing piece) - 4 mg Nicotine polacrilex (equal to 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.

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
55301-428-44 55301-428 AAFES/Your Military Exchanges 100 BLISTER PACK in 1 CARTON (55301-428-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
55301-429-44 55301-429 AAFES/Your Military Exchanges 100 BLISTER PACK in 1 CARTON (55301-429-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
55301-503-44 55301-503 AAFES/Your Military Exchanges 100 BLISTER PACK in 1 CARTON (55301-503-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
55301-504-44 55301-504 AAFES/Your Military Exchanges 100 BLISTER PACK in 1 CARTON (55301-504-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
46122-448-58 46122-448 AmerisourceBergen (Good Neighbor Pharmacy) 46122 40 BLISTER PACK in 1 CARTON (46122-448-58) / 1 GUM, CHEWING in 1 BLISTER PACK January 9, 2018
46122-449-58 46122-449 AmerisourceBergen (Good Neighbor Pharmacy) 46122 40 BLISTER PACK in 1 CARTON (46122-449-58) / 1 GUM, CHEWING in 1 BLISTER PACK January 9, 2018
46122-717-60 46122-717 AmerisourceBergen (Good Neighbor Pharmacy) 46122 20 BLISTER PACK in 1 CARTON (46122-717-60) / 1 GUM, CHEWING in 1 BLISTER PACK September 30, 2022
46122-718-60 46122-718 AmerisourceBergen (Good Neighbor Pharmacy) 46122 20 BLISTER PACK in 1 CARTON (46122-718-60) / 1 GUM, CHEWING in 1 BLISTER PACK February 22, 2023
46122-720-25 46122-720 AmerisourceBergen (Good Neighbor Pharmacy) 46122 110 BLISTER PACK in 1 CARTON (46122-720-25) / 1 GUM, CHEWING in 1 BLISTER PACK February 14, 2023
46122-725-71 46122-725 AmerisourceBergen (Good Neighbor Pharmacy) 46122 50 BLISTER PACK in 1 CARTON (46122-725-71) / 1 GUM, CHEWING in 1 BLISTER PACK February 10, 2023
70000-0341-1 70000-0341 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 50 BLISTER PACK in 1 CARTON (70000-0341-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0342-1 70000-0342 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 20 BLISTER PACK in 1 CARTON (70000-0342-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0343-1 70000-0343 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 10 BLISTER PACK in 1 CARTON (70000-0343-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0344-1 70000-0344 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 20 BLISTER PACK in 1 CARTON (70000-0344-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0344-2 70000-0344 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 100 BLISTER PACK in 1 CARTON (70000-0344-2) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0345-1 70000-0345 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 50 BLISTER PACK in 1 CARTON (70000-0345-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0346-1 70000-0346 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 20 BLISTER PACK in 1 CARTON (70000-0346-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0347-1 70000-0347 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 10 BLISTER PACK in 1 CARTON (70000-0347-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0348-1 70000-0348 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 20 BLISTER PACK in 1 CARTON (70000-0348-1) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
70000-0348-2 70000-0348 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 100 BLISTER PACK in 1 CARTON (70000-0348-2) / 1 GUM, CHEWING in 1 BLISTER PACK July 3, 2018
69842-024-15 69842-024 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-024-15) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-024-16 69842-024 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-024-16) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-024-44 69842-024 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-024-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-024-79 69842-024 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-024-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-025-15 69842-025 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-025-15) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-025-16 69842-025 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-025-16) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-025-44 69842-025 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-025-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-025-79 69842-025 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-025-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-026-44 69842-026 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-026-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-028-44 69842-028 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-028-44) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-216-15 69842-216 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-216-15) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-216-16 69842-216 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-216-16) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-216-44 69842-216 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-216-44) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-217-15 69842-217 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-217-15) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-217-16 69842-217 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-217-16) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-217-44 69842-217 CVS Pharmacy 100 BLISTER PACK in 1 CARTON (69842-217-44) / 1 GUM, CHEWING in 1 BLISTER PACK May 1, 2016
69842-428-16 69842-428 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-428-16) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-428-22 69842-428 CVS Pharmacy 120 BLISTER PACK in 1 CARTON (69842-428-22) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-428-79 69842-428 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-428-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-430-16 69842-430 CVS Pharmacy 160 BLISTER PACK in 1 CARTON (69842-430-16) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-430-22 69842-430 CVS Pharmacy 120 BLISTER PACK in 1 CARTON (69842-430-22) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-430-79 69842-430 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-430-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-608-15 69842-608 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-608-15) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-608-50 69842-608 CVS Pharmacy 50 BLISTER PACK in 1 CARTON (69842-608-50) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-608-79 69842-608 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-608-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-608-98 69842-608 CVS Pharmacy 170 BLISTER PACK in 1 CARTON (69842-608-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-609-15 69842-609 CVS Pharmacy 20 BLISTER PACK in 1 CARTON (69842-609-15) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-609-50 69842-609 CVS Pharmacy 50 BLISTER PACK in 1 CARTON (69842-609-50) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-609-79 69842-609 CVS Pharmacy 10 BLISTER PACK in 1 CARTON (69842-609-79) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
69842-609-98 69842-609 CVS Pharmacy 170 BLISTER PACK in 1 CARTON (69842-609-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
68016-280-49 68016-280 Chain Drug Consortium, LLC 4 BLISTER PACK in 1 CARTON (68016-280-49) / 10 GUM, CHEWING in 1 BLISTER PACK July 1, 2013
68016-281-49 68016-281 Chain Drug Consortium, LLC 4 BLISTER PACK in 1 CARTON (68016-281-49) / 10 GUM, CHEWING in 1 BLISTER PACK June 1, 2013
68016-284-44 68016-284 Chain Drug Consortium, LLC 10 BLISTER PACK in 1 CARTON (68016-284-44) / 10 GUM, CHEWING in 1 BLISTER PACK June 1, 2013
68016-285-44 68016-285 Chain Drug Consortium, LLC 10 BLISTER PACK in 1 CARTON (68016-285-44) / 10 GUM, CHEWING in 1 BLISTER PACK September 1, 2013
68016-292-44 68016-292 Chain Drug Consortium, LLC 100 BLISTER PACK in 1 CARTON (68016-292-44) / 1 GUM, CHEWING in 1 BLISTER PACK October 1, 2017
68016-293-44 68016-293 Chain Drug Consortium, LLC 100 BLISTER PACK in 1 CARTON (68016-293-44) / 1 GUM, CHEWING in 1 BLISTER PACK October 1, 2017
68016-559-00 68016-559 Chain Drug Consortium, LLC 2 BLISTER PACK in 1 CARTON (68016-559-00) / 10 GUM, CHEWING in 1 BLISTER PACK October 1, 2014
68016-560-00 68016-560 Chain Drug Consortium, LLC 2 BLISTER PACK in 1 CARTON (68016-560-00) / 10 GUM, CHEWING in 1 BLISTER PACK October 1, 2014
55910-796-20 55910-796 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 20 BLISTER PACK in 1 CARTON (55910-796-20) / 1 GUM, CHEWING in 1 BLISTER PACK November 1, 2023
55910-933-10 55910-933 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 10 BLISTER PACK in 1 CARTON (55910-933-10) / 1 GUM, CHEWING in 1 BLISTER PACK October 25, 2023
55910-976-20 55910-976 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 20 BLISTER PACK in 1 CARTON (55910-976-20) / 1 GUM, CHEWING in 1 BLISTER PACK April 1, 2025
55319-966-20 55319-966 Family Dollar (FAMILY WELLNESS) 20 BLISTER PACK in 1 CARTON (55319-966-20) / 1 GUM, CHEWING in 1 BLISTER PACK July 1, 2023
63443-0101-1 63443-0101 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0101-1) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2005
63443-0102-1 63443-0102 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0102-1) / 10 GUM, CHEWING in 1 BLISTER PACK October 30, 2006
63443-0121-1 63443-0121 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0121-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 13, 2006
63443-0201-1 63443-0201 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0201-1) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2005
63443-0202-1 63443-0202 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0202-1) / 10 GUM, CHEWING in 1 BLISTER PACK October 30, 2006
63443-0221-1 63443-0221 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0221-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 13, 2006
63443-0838-1 63443-0838 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0838-1) / 10 GUM, CHEWING in 1 BLISTER PACK February 10, 2022
63443-0839-1 63443-0839 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-0839-1) / 10 GUM, CHEWING in 1 BLISTER PACK February 10, 2022
63443-1032-1 63443-1032 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1032-1) / 10 GUM, CHEWING in 1 BLISTER PACK October 11, 2011
63443-1033-1 63443-1033 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1033-1) / 10 GUM, CHEWING in 1 BLISTER PACK October 11, 2011
63443-1151-1 63443-1151 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1151-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 26, 2014
63443-1152-1 63443-1152 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1152-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 26, 2014
63443-1560-1 63443-1560 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1560-1) / 10 GUM, CHEWING in 1 BLISTER PACK August 31, 2016
63443-1561-1 63443-1561 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-1561-1) / 10 GUM, CHEWING in 1 BLISTER PACK August 31, 2016
63443-2853-1 63443-2853 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-2853-1) / 10 GUM, CHEWING in 1 BLISTER PACK September 24, 2018
63443-2854-1 63443-2854 Fertin Pharma A/S 660 BLISTER PACK in 1 PACKAGE (63443-2854-1) / 10 GUM, CHEWING in 1 BLISTER PACK September 24, 2018
63443-5080-1 63443-5080 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-5080-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 30, 2019
63443-5081-1 63443-5081 Fertin Pharma A/S 660 BLISTER PACK in 1 BOX (63443-5081-1) / 10 GUM, CHEWING in 1 BLISTER PACK June 30, 2019
72224-924-10 72224-924 Lucy Goods, Inc. 100 BLISTER PACK in 1 CARTON (72224-924-10) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2025
72224-925-10 72224-925 Lucy Goods, Inc. 100 BLISTER PACK in 1 CARTON (72224-925-10) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2025
72224-927-10 72224-927 Lucy Goods, Inc. 100 BLISTER PACK in 1 CARTON (72224-927-10) / 1 GUM, CHEWING in 1 BLISTER PACK May 30, 2025
72224-933-10 72224-933 Lucy Goods, Inc. 100 BLISTER PACK in 1 CARTON (72224-933-10) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2025
59726-420-00 59726-420 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-420-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-421-00 59726-421 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-421-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-428-00 59726-428 P & L Development, LLC 1 BAG in 1 DRUM (59726-428-00) / 947917 GUM, CHEWING in 1 BAG November 30, 2024
59726-429-00 59726-429 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-429-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-482-00 59726-482 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-482-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-496-00 59726-496 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-496-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-499-00 59726-499 P & L Development, LLC 1 BAG in 1 DRUM (59726-499-00) / 947917 GUM, CHEWING in 1 BAG October 22, 2024
59726-503-00 59726-503 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-503-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-605-00 59726-605 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-605-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-608-00 59726-608 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-608-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-609-00 59726-609 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-609-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-612-00 59726-612 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-612-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
59726-613-00 59726-613 P & L Development, LLC 947917 BLISTER PACK in 1 CONTAINER (59726-613-00) / 947917 GUM, CHEWING in 1 BLISTER PACK October 22, 2024
56062-428-44 56062-428 Publix Supermarkets, Inc. 10 BLISTER PACK in 1 CARTON (56062-428-44) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
56062-429-44 56062-429 Publix Supermarkets, Inc. 10 BLISTER PACK in 1 CARTON (56062-429-44) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
56062-503-44 56062-503 Publix Supermarkets, Inc. 10 BLISTER PACK in 1 CARTON (56062-503-44) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
56062-504-44 56062-504 Publix Supermarkets, Inc. 10 BLISTER PACK in 1 CARTON (56062-504-44) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
56062-608-62 56062-608 Publix Supermarkets, Inc. 11 BLISTER PACK in 1 CARTON (56062-608-62) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
56062-609-62 56062-609 Publix Supermarkets, Inc. 11 BLISTER PACK in 1 CARTON (56062-609-62) / 10 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
84720-927-03 84720-927 Quitine LLC 300 BLISTER PACK in 1 CARTON (84720-927-03) / 1 GUM, CHEWING in 1 BLISTER PACK December 15, 2024
84720-933-03 84720-933 Quitine LLC 300 BLISTER PACK in 1 CARTON (84720-933-03) / 1 GUM, CHEWING in 1 BLISTER PACK December 15, 2024
57237-322-01 57237-322 Rising Pharma Holdings, Inc. 100 BLISTER PACK in 1 CARTON (57237-322-01) / 1 GUM, CHEWING in 1 BLISTER PACK August 10, 2023
57237-322-11 57237-322 Rising Pharma Holdings, Inc. 110 BLISTER PACK in 1 CARTON (57237-322-11) / 1 GUM, CHEWING in 1 BLISTER PACK December 8, 2025
57237-322-50 57237-322 Rising Pharma Holdings, Inc. 50 BLISTER PACK in 1 CARTON (57237-322-50) / 1 GUM, CHEWING in 1 BLISTER PACK December 8, 2025
57237-323-01 57237-323 Rising Pharma Holdings, Inc. 100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACK August 10, 2023
57237-323-11 57237-323 Rising Pharma Holdings, Inc. 110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACK December 8, 2025
57237-323-50 57237-323 Rising Pharma Holdings, Inc. 50 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACK December 8, 2025
11822-2331-2 11822-2331 Rite Aid Corporation 100 BLISTER PACK in 1 CARTON (11822-2331-2) / 1 GUM, CHEWING in 1 BLISTER PACK January 31, 2020
11822-2331-3 11822-2331 Rite Aid Corporation 20 BLISTER PACK in 1 CARTON (11822-2331-3) / 1 GUM, CHEWING in 1 BLISTER PACK January 31, 2020
0363-1420-98 0363-1420 Walgreens 170 BLISTER PACK in 1 CARTON (0363-1420-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-1421-98 0363-1421 Walgreens 170 BLISTER PACK in 1 CARTON (0363-1421-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-1608-62 0363-1608 Walgreens 110 BLISTER PACK in 1 CARTON (0363-1608-62) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-1608-98 0363-1608 Walgreens 170 BLISTER PACK in 1 CARTON (0363-1608-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-1609-62 0363-1609 Walgreens 110 BLISTER PACK in 1 CARTON (0363-1609-62) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-1609-98 0363-1609 Walgreens 170 BLISTER PACK in 1 CARTON (0363-1609-98) / 1 GUM, CHEWING in 1 BLISTER PACK January 1, 2014
0363-3290-10 0363-3290 Walgreens 100 BLISTER PACK in 1 CARTON (0363-3290-10) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
0363-9240-10 0363-9240 Walgreens 100 BLISTER PACK in 1 CARTON (0363-9240-10) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
0363-9240-16 0363-9240 Walgreens 160 BLISTER PACK in 1 CARTON (0363-9240-16) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
0363-9260-10 0363-9260 Walgreens 100 BLISTER PACK in 1 CARTON (0363-9260-10) / 1 GUM, CHEWING in 1 BLISTER PACK January 31, 2020
0363-9270-10 0363-9270 Walgreens 100 BLISTER PACK in 1 CARTON (0363-9270-10) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2021
0363-9270-16 0363-9270 Walgreens 160 BLISTER PACK in 1 CARTON (0363-9270-16) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2021
0363-9270-20 0363-9270 Walgreens 20 BLISTER PACK in 1 CARTON (0363-9270-20) / 1 GUM, CHEWING in 1 BLISTER PACK April 30, 2021
0363-9330-10 0363-9330 Walgreens 100 BLISTER PACK in 1 CARTON (0363-9330-10) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
0363-9330-16 0363-9330 Walgreens 160 BLISTER PACK in 1 CARTON (0363-9330-16) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
0363-9330-20 0363-9330 Walgreens 20 BLISTER PACK in 1 CARTON (0363-9330-20) / 1 GUM, CHEWING in 1 BLISTER PACK October 30, 2020
55301-428 55301-428 AAFES/Your Military Exchanges — January 1, 2014
55301-429 55301-429 AAFES/Your Military Exchanges — January 1, 2014
55301-503 55301-503 AAFES/Your Military Exchanges — January 1, 2014
55301-504 55301-504 AAFES/Your Military Exchanges — January 1, 2014
46122-448 46122-448 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — January 9, 2018
46122-449 46122-449 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — January 9, 2018
46122-717 46122-717 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — September 30, 2022
46122-718 46122-718 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 22, 2023
46122-720 46122-720 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 14, 2023
46122-725 46122-725 AmerisourceBergen (Good Neighbor Pharmacy) 46122 — February 10, 2023
70000-0341 70000-0341 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0342 70000-0342 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0343 70000-0343 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0344 70000-0344 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0345 70000-0345 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0346 70000-0346 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0347 70000-0347 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
70000-0348 70000-0348 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — July 3, 2018
69842-024 69842-024 CVS Pharmacy — January 1, 2014
69842-025 69842-025 CVS Pharmacy — January 1, 2014
69842-026 69842-026 CVS Pharmacy — January 1, 2014
69842-028 69842-028 CVS Pharmacy — January 1, 2014
69842-216 69842-216 CVS Pharmacy — May 1, 2016
69842-217 69842-217 CVS Pharmacy — May 1, 2016
69842-428 69842-428 CVS Pharmacy — January 1, 2014
69842-430 69842-430 CVS Pharmacy — January 1, 2014
69842-608 69842-608 CVS Pharmacy — January 1, 2014
69842-609 69842-609 CVS Pharmacy — January 1, 2014
68016-280 68016-280 Chain Drug Consortium, LLC — July 1, 2013
68016-281 68016-281 Chain Drug Consortium, LLC — June 1, 2013
68016-284 68016-284 Chain Drug Consortium, LLC — June 1, 2013
68016-285 68016-285 Chain Drug Consortium, LLC — September 1, 2013
68016-292 68016-292 Chain Drug Consortium, LLC — October 1, 2017
68016-293 68016-293 Chain Drug Consortium, LLC — October 1, 2017
68016-559 68016-559 Chain Drug Consortium, LLC — October 1, 2014
68016-560 68016-560 Chain Drug Consortium, LLC — October 1, 2014
55910-796 55910-796 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — November 1, 2023
55910-933 55910-933 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — October 25, 2023
55910-976 55910-976 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — April 1, 2025
55319-966 55319-966 Family Dollar (FAMILY WELLNESS) — July 1, 2023
63443-0101 63443-0101 Fertin Pharma A/S — January 1, 2005
63443-0102 63443-0102 Fertin Pharma A/S — October 30, 2006
63443-0121 63443-0121 Fertin Pharma A/S — June 13, 2006
63443-0201 63443-0201 Fertin Pharma A/S — January 1, 2005
63443-0202 63443-0202 Fertin Pharma A/S — October 30, 2006
63443-0221 63443-0221 Fertin Pharma A/S — June 13, 2006
63443-0838 63443-0838 Fertin Pharma A/S — February 10, 2022
63443-0839 63443-0839 Fertin Pharma A/S — February 10, 2022
63443-1032 63443-1032 Fertin Pharma A/S — October 11, 2011
63443-1033 63443-1033 Fertin Pharma A/S — October 11, 2011
63443-1151 63443-1151 Fertin Pharma A/S — June 26, 2014
63443-1152 63443-1152 Fertin Pharma A/S — June 26, 2014
63443-1560 63443-1560 Fertin Pharma A/S — August 31, 2016
63443-1561 63443-1561 Fertin Pharma A/S — August 31, 2016
63443-2853 63443-2853 Fertin Pharma A/S — September 24, 2018
63443-2854 63443-2854 Fertin Pharma A/S — September 24, 2018
63443-5080 63443-5080 Fertin Pharma A/S — June 30, 2019
63443-5081 63443-5081 Fertin Pharma A/S — June 30, 2019
72224-924 72224-924 Lucy Goods, Inc. — April 30, 2025
72224-925 72224-925 Lucy Goods, Inc. — April 30, 2025
72224-927 72224-927 Lucy Goods, Inc. — April 30, 2025
72224-933 72224-933 Lucy Goods, Inc. — April 30, 2025
59726-420 59726-420 P & L Development, LLC — October 22, 2024
59726-421 59726-421 P & L Development, LLC — October 22, 2024
59726-428 59726-428 P & L Development, LLC — November 30, 2024
59726-429 59726-429 P & L Development, LLC — October 22, 2024
59726-482 59726-482 P & L Development, LLC — October 22, 2024
59726-496 59726-496 P & L Development, LLC — October 22, 2024
59726-499 59726-499 P & L Development, LLC — October 22, 2024
59726-503 59726-503 P & L Development, LLC — October 22, 2024
59726-605 59726-605 P & L Development, LLC — October 22, 2024
59726-608 59726-608 P & L Development, LLC — October 22, 2024
59726-609 59726-609 P & L Development, LLC — October 22, 2024
59726-612 59726-612 P & L Development, LLC — October 22, 2024
59726-613 59726-613 P & L Development, LLC — October 22, 2024
56062-428 56062-428 Publix Supermarkets, Inc. — January 1, 2014
56062-429 56062-429 Publix Supermarkets, Inc. — January 1, 2014
56062-503 56062-503 Publix Supermarkets, Inc. — January 1, 2014
56062-504 56062-504 Publix Supermarkets, Inc. — January 1, 2014
56062-608 56062-608 Publix Supermarkets, Inc. — January 1, 2014
56062-609 56062-609 Publix Supermarkets, Inc. — January 1, 2014
84720-927 84720-927 Quitine LLC — December 15, 2024
84720-933 84720-933 Quitine LLC — December 15, 2024
57237-322 57237-322 Rising Pharma Holdings, Inc. — August 10, 2023
57237-323 57237-323 Rising Pharma Holdings, Inc. — August 10, 2023
11822-2331 11822-2331 Rite Aid Corporation — January 31, 2020
0363-1420 0363-1420 Walgreens — January 1, 2014
0363-1421 0363-1421 Walgreens — January 1, 2014
0363-1608 0363-1608 Walgreens — January 1, 2014
0363-1609 0363-1609 Walgreens — January 1, 2014
0363-3290 0363-3290 Walgreens — October 30, 2020
0363-9240 0363-9240 Walgreens — October 30, 2020
0363-9260 0363-9260 Walgreens — January 31, 2020
0363-9270 0363-9270 Walgreens — April 30, 2021
0363-9330 0363-9330 Walgreens — October 30, 2020

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.