On this page

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. Report adverse events to FDA MedWatch.

Overview

Brand name
Nicotine transdermal system step 1
Generic name
Nicotine
Dosage form
Patch, Extended Release
Route
—
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
41
Packages
51
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 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
—
Presentations
92

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
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 20250610). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250610 HUMAN OTC DRUG · 20250610 HUMAN OTC DRUG · 20240726 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 User’s 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 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 (21mg). Start with STEP 2 (14mg) , for 6 weeks, then STEP 3 (7mg) 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 • stop using the patch at the end of 10 weeks. If you started with STEP 2 , 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, or use a nicotine gum 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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Do Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum 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 • 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 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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6383 NDC: 50090-6383-0 24 h in a PATCH / 14 in a CARTON

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
50090-6383-0 50090-6383 A-S Medication Solutions 14 PATCH in 1 CARTON (50090-6383-0) / 24 h in 1 PATCH February 28, 2023
59779-443-74 59779-443 CVS Pharmacy 14 PATCH in 1 CARTON (59779-443-74) / 24 h in 1 PATCH August 10, 2015
59779-445-74 59779-445 CVS Pharmacy 14 PATCH in 1 CARTON (59779-445-74) / 24 h in 1 PATCH August 10, 2015
59779-448-02 59779-448 CVS Pharmacy 2 POUCH in 1 CARTON (59779-448-02) / 24 h in 1 POUCH October 18, 2016
59779-448-70 59779-448 CVS Pharmacy 7 PATCH in 1 CARTON (59779-448-70) / 24 h in 1 PATCH August 10, 2015
59779-448-74 59779-448 CVS Pharmacy 14 PATCH in 1 CARTON (59779-448-74) / 24 h in 1 PATCH August 10, 2015
63868-734-14 63868-734 Chain Drug Marketing Association INC 14 PATCH in 1 CARTON (63868-734-14) / 24 h in 1 PATCH October 31, 2020
63868-735-14 63868-735 Chain Drug Marketing Association INC 14 PATCH in 1 CARTON (63868-735-14) / 24 h in 1 PATCH October 31, 2020
55910-313-02 55910-313 DOLGENCORP, LLC 2 PATCH in 1 CARTON (55910-313-02) / 24 h in 1 PATCH June 15, 2019
43598-446-70 43598-446 Dr. Reddy's Laboratories Inc. 7 PATCH in 1 CARTON (43598-446-70) / 24 h in 1 PATCH March 31, 2019
43598-446-74 43598-446 Dr. Reddy's Laboratories Inc. 14 PATCH in 1 CARTON (43598-446-74) / 24 h in 1 PATCH March 31, 2019
43598-447-70 43598-447 Dr. Reddy's Laboratories Inc. 7 PATCH in 1 CARTON (43598-447-70) / 24 h in 1 PATCH March 31, 2019
43598-447-74 43598-447 Dr. Reddy's Laboratories Inc. 14 PATCH in 1 CARTON (43598-447-74) / 24 h in 1 PATCH April 5, 2019
43598-448-28 43598-448 Dr. Reddy's Laboratories Inc. 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH March 31, 2019
43598-448-70 43598-448 Dr. Reddy's Laboratories Inc. 7 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH March 31, 2019
43598-448-74 43598-448 Dr. Reddy's Laboratories Inc. 14 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH March 31, 2019
60429-443-14 60429-443 Golden State Medical Supply, Inc. 14 PATCH in 1 CARTON (60429-443-14) / 24 h in 1 PATCH September 23, 2015
60429-444-14 60429-444 Golden State Medical Supply, Inc. 14 PATCH in 1 CARTON (60429-444-14) / 24 h in 1 PATCH September 23, 2015
60429-445-14 60429-445 Golden State Medical Supply, Inc. 14 PATCH in 1 CARTON (60429-445-14) / 24 h in 1 PATCH September 23, 2015
58316-006-01 58316-006 Haleon US Holdings LLC 6300 POUCH in 1 CARTON (58316-006-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
58316-007-01 58316-007 Haleon US Holdings LLC 6300 POUCH in 1 CARTON (58316-007-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
58316-008-01 58316-008 Haleon US Holdings LLC 6300 POUCH in 1 PACKAGE (58316-008-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
58316-009-02 58316-009 Haleon US Holdings LLC 6300 POUCH in 1 CARTON (58316-009-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
58316-010-02 58316-010 Haleon US Holdings LLC 6300 POUCH in 1 CARTON (58316-010-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
58316-011-02 58316-011 Haleon US Holdings LLC 6300 POUCH in 1 PACKAGE (58316-011-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH June 1, 2022
11822-4973-0 11822-4973 Rite Aid Corporation 14 PATCH in 1 CARTON (11822-4973-0) / 24 h in 1 PATCH May 14, 2015
11822-4974-0 11822-4974 Rite Aid Corporation 14 PATCH in 1 CARTON (11822-4974-0) / 24 h in 1 PATCH May 14, 2015
11822-4975-0 11822-4975 Rite Aid Corporation 7 PATCH in 1 CARTON (11822-4975-0) / 24 h in 1 PATCH May 14, 2015
11822-4975-1 11822-4975 Rite Aid Corporation 14 PATCH in 1 CARTON (11822-4975-1) / 24 h in 1 PATCH May 14, 2015
11822-4975-2 11822-4975 Rite Aid Corporation 2 PATCH in 1 CARTON (11822-4975-2) / 24 h in 1 PATCH May 14, 2015
0536-1106-88 0536-1106 Rugby Laboratories 14 PATCH in 1 CARTON (0536-1106-88) / 24 h in 1 PATCH April 1, 2016
0536-1107-88 0536-1107 Rugby Laboratories 14 PATCH in 1 CARTON (0536-1107-88) / 24 h in 1 PATCH April 1, 2016
0536-1108-88 0536-1108 Rugby Laboratories 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH April 1, 2016
70677-1264-1 70677-1264 Strategic Sourcing Services LLC 14 PATCH in 1 CARTON (70677-1264-1) / 24 h in 1 PATCH January 10, 2025
70677-1265-1 70677-1265 Strategic Sourcing Services LLC 14 PATCH in 1 CARTON (70677-1265-1) / 24 h in 1 PATCH January 10, 2025
70677-1266-1 70677-1266 Strategic Sourcing Services LLC 14 PATCH in 1 CARTON (70677-1266-1) / 24 h in 1 PATCH January 10, 2025
70677-1266-2 70677-1266 Strategic Sourcing Services LLC 28 PATCH in 1 CARTON (70677-1266-2) / 24 h in 1 PATCH January 10, 2025
11673-194-02 11673-194 Target Corporation 14 PATCH in 1 CARTON (11673-194-02) / 24 h in 1 PATCH February 16, 2000
11673-195-02 11673-195 Target Corporation 14 PATCH in 1 CARTON (11673-195-02) / 24 h in 1 PATCH February 16, 2000
11673-196-02 11673-196 Target Corporation 14 PATCH in 1 CARTON (11673-196-02) / 24 h in 1 PATCH February 16, 2000
59450-001-74 59450-001 The Kroger Co. 14 PATCH in 1 CARTON (59450-001-74) / 24 h in 1 PATCH August 25, 2015
59450-002-74 59450-002 The Kroger Co. 14 PATCH in 1 CARTON (59450-002-74) / 24 h in 1 PATCH August 25, 2015
59450-003-74 59450-003 The Kroger Co. 14 PATCH in 1 CARTON (59450-003-74) / 24 h in 1 PATCH August 25, 2015
49035-194-01 49035-194 Wal-Mart Stores Inc 7 PATCH in 1 CARTON (49035-194-01) / 24 h in 1 PATCH October 19, 2010
49035-194-02 49035-194 Wal-Mart Stores Inc 14 PATCH in 1 CARTON (49035-194-02) / 24 h in 1 PATCH October 19, 2010
49035-195-02 49035-195 Wal-Mart Stores Inc 14 PATCH in 1 CARTON (49035-195-02) / 24 h in 1 PATCH October 19, 2010
49035-196-02 49035-196 Wal-Mart Stores Inc 14 PATCH in 1 CARTON (49035-196-02) / 24 h in 1 PATCH October 19, 2010
0363-0451-74 0363-0451 Walgreens Company 14 PATCH in 1 CARTON (0363-0451-74) / 24 h in 1 PATCH September 1, 2015
0363-0455-70 0363-0455 Walgreens Company 7 PATCH in 1 CARTON (0363-0455-70) / 24 h in 1 PATCH September 1, 2015
0363-0455-74 0363-0455 Walgreens Company 14 PATCH in 1 CARTON (0363-0455-74) / 24 h in 1 PATCH September 1, 2015
0363-0457-74 0363-0457 Walgreens Company 14 PATCH in 1 CARTON (0363-0457-74) / 24 h in 1 PATCH September 1, 2015
50090-6383 50090-6383 A-S Medication Solutions — May 14, 2015
59779-443 59779-443 CVS Pharmacy — August 6, 2015
59779-445 59779-445 CVS Pharmacy — August 6, 2015
59779-448 59779-448 CVS Pharmacy — August 6, 2015
63868-734 63868-734 Chain Drug Marketing Association INC — October 31, 2020
63868-735 63868-735 Chain Drug Marketing Association INC — October 31, 2020
55910-313 55910-313 DOLGENCORP, LLC — June 15, 2019
43598-446 43598-446 Dr. Reddy's Laboratories Inc. — May 14, 2015
43598-447 43598-447 Dr. Reddy's Laboratories Inc. — May 14, 2015
43598-448 43598-448 Dr. Reddy's Laboratories Inc. — May 14, 2015
60429-443 60429-443 Golden State Medical Supply, Inc. — November 12, 1999
60429-444 60429-444 Golden State Medical Supply, Inc. — November 12, 1999
60429-445 60429-445 Golden State Medical Supply, Inc. — November 12, 1999
58316-006 58316-006 Haleon US Holdings LLC — June 1, 2022
58316-007 58316-007 Haleon US Holdings LLC — June 1, 2022
58316-008 58316-008 Haleon US Holdings LLC — June 1, 2022
58316-009 58316-009 Haleon US Holdings LLC — June 1, 2022
58316-010 58316-010 Haleon US Holdings LLC — June 1, 2022
58316-011 58316-011 Haleon US Holdings LLC — June 1, 2022
11822-4973 11822-4973 Rite Aid Corporation — May 14, 2015
11822-4974 11822-4974 Rite Aid Corporation — May 14, 2015
11822-4975 11822-4975 Rite Aid Corporation — May 14, 2015
0536-1106 0536-1106 Rugby Laboratories — April 1, 2016
0536-1107 0536-1107 Rugby Laboratories — April 1, 2016
0536-1108 0536-1108 Rugby Laboratories — April 1, 2016
68196-194 68196-194 Sam's West Inc — March 2, 2012
70677-1264 70677-1264 Strategic Sourcing Services LLC — November 2, 2015
70677-1265 70677-1265 Strategic Sourcing Services LLC — November 2, 2015
70677-1266 70677-1266 Strategic Sourcing Services LLC — November 2, 2015
11673-194 11673-194 Target Corporation — February 16, 2000
11673-195 11673-195 Target Corporation — February 16, 2000
11673-196 11673-196 Target Corporation — February 16, 2000
59450-001 59450-001 The Kroger Co. — August 25, 2015
59450-002 59450-002 The Kroger Co. — August 25, 2015
59450-003 59450-003 The Kroger Co. — August 25, 2015
49035-194 49035-194 Wal-Mart Stores Inc — October 19, 2010
49035-195 49035-195 Wal-Mart Stores Inc — October 19, 2010
49035-196 49035-196 Wal-Mart Stores Inc — October 19, 2010
0363-0451 0363-0451 Walgreens Company — September 1, 2015
0363-0455 0363-0455 Walgreens Company — September 1, 2015
0363-0457 0363-0457 Walgreens Company — September 1, 2015

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 · 12 sections on this page.