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Nicotine transdermal system

nicotine · Nicotine transdermal system is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by 6 manufacturers.

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Transdermal
Manufacturers
6
+ 1 repackager labels

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Drug facts

Generic name
nicotine
Active ingredients
Nicotine
Dosage forms
Film, extended release, Kit, Patch, extended release
Label holder
Wal-Mart Stores Inc
FDA application
NDA020165
Label updated
03/13/2026

Active ingredients

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

Purpose

Stop smoking aid

Uses

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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 healthcare 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 before use

  • 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

  • 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

  • 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)

Pregnancy or breastfeeding

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.

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.

Inactive ingredients

Ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Questions?

Call 1-888-287-1915

Forms and strengths

From the FDA NDC Directory · 13 product codes

Dosage formStrengthRouteNDCs
Film, extended release7 mg/24htransdermal1
Film, extended release14 mg/24htransdermal1
Film, extended release21 mg/24htransdermal1
Kit-transdermal2
Patch, extended release7 mg/24htransdermal2
Patch, extended release14 mg/24htransdermal2
Patch, extended release21 mg/24htransdermal4

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $1.32 to $1.99 per tablet, capsule or unit across 4 package codes.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 40,213 reports that list nicotine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective5,266
  • Nausea3,270
  • Application site erythema3,142
  • Application site pruritus3,069
  • Nicotine dependence2,751
  • Dizziness1,910
  • Headache1,645
  • Malaise1,636
  • Wrong technique in product usage process1,257
  • Vomiting1,255

To report a side effect, use FDA MedWatch.

Manufacturers and labels

7 FDA labels · 1 from repackagers

  • Wal-Mart Stores IncShown hereNDA020165 · Label 01/26/2026 · NDC 49035-194, 49035-195, 49035-196Full label
  • Dr. Reddy's Laboratories Inc.NDA020076 · Label 07/25/2024 · NDC 55741-449Full label
  • Dr. Reddys Laboratories Inc.NDA020076 · Label 07/25/2024 · NDC 43598-445Full label
  • EXELAN PHARMACEUTICALS, INC.ANDA074612 · Label 06/01/2025 · NDC 76282-782, 76282-783, 76282-781Full label
  • Sam's West IncNDA020165 · Label 06/10/2025 · NDC 68196-194Full label
  • Target CorporationNDA020165 · Label 06/10/2025 · NDC 11673-194, 11673-195, 11673-196Full label
Repackager labels (1)
  • A-S Medication Solutions03/13/2026

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Nicotine transdermal system: common questions

What is Nicotine transdermal system used for?
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Nicotine transdermal system a prescription drug?
No. Nicotine transdermal system is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Nicotine transdermal system?
Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
Who makes Nicotine transdermal system?
6 manufacturers list Nicotine transdermal system with the FDA, including Wal-Mart Stores Inc, Dr. Reddy's Laboratories Inc., Dr. Reddys Laboratories Inc.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/13/2026 · Label text is shown as published by the manufacturer. Not medical advice