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NICODERM

nicotine · Patch, Extended Release

Over-the-counter NDA RLD 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
NICODERM CQ
Generic name
nicotine
Dosage form
Patch, Extended Release
Route
Transdermal
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
9
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Nicotine 14 mg/24h 359817 View
Nicotine 21 mg/24h 359817 View
Nicotine 7 mg/24h 359817 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Patch, Extended Release
Route of administration
Transdermal
Presentations
12

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
020165
Application type
NDA · New Drug Application
Approval date
November 7, 1991
Sponsor
CHATTEM SANOFI
Products on application
3
Submissions recorded
30
Products approved under application 020165.
Product Trade name Form Strength Ingredient Status TE Flags
020165-004 NICODERM CQ FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD RS
020165-005 NICODERM CQ FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD
020165-006 NICODERM CQ FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020165.
Type No. Action Status Date Review
Supplement 50 Manufacturing (CMC) Approved November 6, 2024 N/A
Supplement 47 Labeling Approved March 4, 2022 Standard
Supplement 38 Labeling Approved May 4, 2016 Standard
Supplement 37 Manufacturing (CMC) Approved October 26, 2015 Standard
Supplement 36 Labeling Approved October 7, 2015 Standard
Supplement 35 Labeling Approved August 6, 2015 Standard
Supplement 34 Labeling Approved February 3, 2015 Standard
Supplement 29 Labeling Approved April 30, 2014 Standard
Supplement 26 Manufacturing (CMC) Approved February 20, 2014 Standard
Supplement 31 Labeling Approved October 31, 2013 Standard
Supplement 28 Labeling Approved September 20, 2012 Standard
Supplement 24 Labeling Approved April 13, 2007 Standard
Supplement 23 Labeling Approved September 15, 2006 Standard
Supplement 20 Labeling Approved August 13, 2002 Standard
Supplement 19 Labeling Approved June 8, 2001 Standard
Supplement 18 Manufacturing (CMC) Approved September 21, 2000 Standard
Supplement 17 Manufacturing (CMC) Approved February 16, 2000 Standard
Supplement 16 Labeling Approved February 16, 2000 Standard
Supplement 15 Manufacturing (CMC) Approved September 14, 1999 Standard
Supplement 12 Manufacturing (CMC) Approved September 11, 1997 Standard
Supplement 14 Manufacturing (CMC) Approved August 21, 1997 Standard
Supplement 13 Manufacturing (CMC) Approved August 21, 1997 Standard
Supplement 11 Efficacy Approved August 2, 1996 Standard
Supplement 9 Manufacturing (CMC) Approved January 23, 1996 Standard
Supplement 6 Manufacturing (CMC) Approved July 19, 1993 Standard
Supplement 5 Manufacturing (CMC) Approved July 19, 1993 Standard
Supplement 4 Manufacturing (CMC) Approved August 12, 1992 Standard
Supplement 3 Manufacturing (CMC) Approved July 22, 1992 Standard
Supplement 2 Manufacturing (CMC) Approved July 22, 1992 Standard
Original application 1 Type 3 - New Dosage Form Approved November 7, 1991 Standard

Review documents

  • 0 · Supplement · January 21, 2025
  • 0 · Supplement · January 21, 2025
  • 0 · Supplement · March 7, 2022
  • 0 · Supplement · March 7, 2022
  • 0 · Supplement · May 6, 2016
  • 0 · Supplement · May 6, 2016
  • 0 · Supplement · November 25, 2015
  • 0 · Supplement · October 13, 2015
  • 0 · Supplement · August 10, 2015
  • 0 · Supplement · August 10, 2015
  • 0 · Supplement · February 17, 2015
  • 0 · Supplement · February 5, 2015
  • 0 · Supplement · May 6, 2014
  • 0 · Supplement · May 1, 2014
  • 0 · Supplement · November 19, 2013
  • 0 · Supplement · November 6, 2013
  • 0 · Supplement · September 24, 2012
  • 0 · Supplement · November 19, 2007
  • 0 · Supplement · April 20, 2007
  • 0 · Supplement · April 19, 2007
  • 0 · Supplement · September 20, 2006
  • 0 · Supplement · September 18, 2006
  • 0 · Supplement · August 13, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250714). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250714

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 before using this product, read the enclosed User's Guide for complete directions and other information begin using the patch on your quit day if you smoke more than 10 cigarettes per day, use according to the following 10-week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10 if you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) for 2 weeks and then stop. steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. remove backing from patch and immediately press onto skin. Hold for 10 seconds. wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User's Guide for safety and handling. you may wear the patch for 16 or 24 hours if you crave cigarettes when you wake up, wear the patch for 24 hours if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning the used patch should be removed and a new one applied to a different skin site at the same time each day do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment. If you feel you need to use the patch 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. an allergy to adhesive tape or have skin problems because you are more likely to get rashes stomach ulcers or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, 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. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

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. an allergy to adhesive tape or have skin problems because you are more likely to get rashes stomach ulcers or diabetes history of seizures

Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, 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 patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 7 mg delivered over 24 hours

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
0135-0194-01 0135-0194 Haleon US Holdings LLC 7 PATCH in 1 CARTON (0135-0194-01) / 24 h in 1 PATCH May 12, 2011
0135-0194-02 0135-0194 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0194-02) / 24 h in 1 PATCH May 12, 2011
0135-0194-03 0135-0194 Haleon US Holdings LLC 1 CARTON in 1 PACKAGE (0135-0194-03) / 21 PATCH in 1 CARTON / 24 h in 1 PATCH May 12, 2011
0135-0194-05 0135-0194 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0194-05) / 24 h in 1 PATCH (0135-0194-08) May 12, 2011
0135-0195-02 0135-0195 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0195-02) / 24 h in 1 PATCH May 12, 2011
0135-0195-03 0135-0195 Haleon US Holdings LLC 1 CARTON in 1 PACKAGE (0135-0195-03) / 21 PATCH in 1 CARTON / 24 h in 1 PATCH May 12, 2011
0135-0195-05 0135-0195 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0195-05) / 24 h in 1 PATCH (0135-0195-08) May 12, 2011
0135-0196-02 0135-0196 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0196-02) / 24 h in 1 PATCH May 12, 2011
0135-0196-05 0135-0196 Haleon US Holdings LLC 14 PATCH in 1 CARTON (0135-0196-05) / 24 h in 1 PATCH (0135-0196-08) May 12, 2011
0135-0194 0135-0194 Haleon US Holdings LLC — May 12, 2011
0135-0195 0135-0195 Haleon US Holdings LLC — May 12, 2011
0135-0196 0135-0196 Haleon US Holdings LLC — May 12, 2011

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.