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NICOTINE

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.

Overview

Brand name
NICOTINE TRANSDERMAL
Generic name
Nicotine
Dosage form
Kit
Route
Transdermal
Marketing category
NDA · NDA
Labeler
Rite Aid Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
3
Packages
3
Data completeness
76% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
Transdermal
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020076
Application type
NDA · New Drug Application
Approval date
November 27, 1991
Sponsor
DR REDDYS LABS SA
Products on application
6
Submissions recorded
33
Products approved under application 020076.
Product Trade name Form Strength Ingredient Status TE Flags
020076-001 HABITROL Film, Extended Release NICOTINE Discontinued —
020076-002 HABITROL Film, Extended Release NICOTINE Discontinued —
020076-003 HABITROL Film, Extended Release NICOTINE Discontinued —
020076-004 HABITROL FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD
020076-005 HABITROL FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD
020076-006 HABITROL FILM, EXTENDED RELEASE NICOTINE Over-the-counter — RLD RS

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 020076.
Type No. Action Status Date Review
Supplement 51 Labeling Approved January 2, 2019 Standard
Supplement 49 Labeling Approved June 27, 2018 Standard
Supplement 45 Labeling Approved July 23, 2017 Standard
Supplement 42 Labeling Approved July 6, 2016 Standard
Supplement 43 Labeling Approved July 5, 2016 Standard
Supplement 41 Labeling Approved May 10, 2016 Standard
Supplement 40 Manufacturing (CMC) Approved May 9, 2016 Standard
Supplement 39 Manufacturing (CMC) Approved April 4, 2016 Standard
Supplement 38 Manufacturing (CMC) Approved January 19, 2016 Standard
Supplement 37 Manufacturing (CMC) Approved November 17, 2015 Standard
Supplement 36 Labeling Approved July 25, 2014 Standard
Supplement 35 Manufacturing (CMC) Approved May 16, 2013 Standard
Supplement 29 Labeling Approved May 5, 2006 Standard
Supplement 28 Labeling Approved November 22, 2005 Standard
Supplement 27 Manufacturing (CMC) Approved October 21, 2004 Standard
Supplement 24 Labeling Approved February 6, 2004 Standard
Supplement 25 Labeling Approved January 21, 2004 Standard
Supplement 21 Labeling Approved July 15, 2002 Standard
Supplement 20 Labeling Approved July 12, 2002 Standard
Supplement 18 Manufacturing (CMC) Approved November 7, 2000 Standard
Supplement 17 Manufacturing (CMC) Approved January 31, 2000 Standard
Supplement 15 Manufacturing (CMC) Approved December 3, 1999 Standard
Supplement 11 Efficacy Approved November 12, 1999 Standard
Supplement 13 Efficacy Approved January 7, 1999 Standard
Supplement 14 Manufacturing (CMC) Approved October 29, 1998 Standard
Supplement 9 Manufacturing (CMC) Approved July 24, 1996 Standard
Supplement 7 Manufacturing (CMC) Approved February 8, 1996 Standard
Supplement 10 Manufacturing (CMC) Approved October 6, 1995 Standard
Supplement 6 Manufacturing (CMC) Approved October 6, 1994 Standard
Supplement 4 Manufacturing (CMC) Approved July 21, 1992 Standard
Supplement 3 Manufacturing (CMC) Approved July 21, 1992 Standard
Supplement 1 Manufacturing (CMC) Approved January 6, 1992 Standard
Original application 1 Type 3 - New Dosage Form Approved November 27, 1991 Standard

Review documents

  • 0 · Supplement · February 1, 2019
  • 0 · Supplement · January 4, 2019
  • 0 · Supplement · July 6, 2018
  • 0 · Supplement · July 6, 2018
  • 0 · Supplement · July 26, 2017
  • 0 · Supplement · July 25, 2017
  • 0 · Supplement · July 18, 2016
  • 0 · Supplement · July 8, 2016
  • 0 · Supplement · July 7, 2016
  • 0 · Supplement · July 7, 2016
  • 0 · Supplement · June 17, 2016
  • 0 · Supplement · May 16, 2016
  • 0 · Supplement · July 29, 2014
  • 0 · Supplement · July 28, 2014
  • 0 · Supplement · May 16, 2006
  • 0 · Supplement · November 30, 2005
  • 0 · Supplement · October 29, 2004
  • 0 · Supplement · March 3, 2004
  • 0 · Supplement · January 22, 2004
  • 0 · Supplement · July 15, 2002
  • 0 · Supplement · July 15, 2002
  • 0 · Supplement · July 12, 2002
  • 0 · Supplement · July 12, 2002
  • 0 · Supplement · November 12, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240725). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240725

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 self-help guide for complete directions and other information • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg patch/day Weeks 1-4 Weeks 5-6 Weeks 7-8 • if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop • apply one new patch every 24 hours on skin that is dry, clean and hairless • remove backing from patch and immediately press onto skin. Hold for 10 seconds. • wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. • the used patch should be removed and a new one applied to a different skin site at the same time each day • if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning • 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 • to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures • stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

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. Do not use • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products 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. 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 • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • 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 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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Do not use • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products

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.

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

Active Ingredient

openFDA Drug Labeling

Active ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours

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
55741-449-56 55741-449 Dr. Reddy's Laboratories Inc. 56 PATCH in 1 CARTON (55741-449-56) / 1 KIT in 1 PATCH May 14, 2015
43598-445-56 43598-445 Dr. Reddys Laboratories Inc. 56 PATCH in 1 CARTON (43598-445-56) / 1 KIT in 1 PATCH May 14, 2015
11822-3627-3 11822-3627 Rite Aid Corporation 56 PATCH in 1 CARTON (11822-3627-3) / 1 KIT in 1 PATCH March 31, 2021
55741-449 55741-449 Dr. Reddy's Laboratories Inc. — May 14, 2015
43598-445 43598-445 Dr. Reddys Laboratories Inc. — May 14, 2015
11822-3627 11822-3627 Rite Aid Corporation — March 31, 2021

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

Generated September 25, 2026 · 9 sections on this page.