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OTC

Medline

nicotine · Medline is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by Medline Industries, LP.

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Transdermal
Manufacturers
1

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

Drug facts

Generic name
nicotine
Active ingredients
Nicotine
Dosage forms
Patch
Label holder
Medline Industries, LP
FDA application
ANDA074611
Label updated
11/04/2025

Active ingredients

(in each patch) Step 1: Nicotine, 21 mg delivered over 24 hours Step 2: Nicotine, 14 mg delivered over 24 hours Step 3: 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 self-help 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 the following schedule below: if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks 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 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. schedule

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 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 ulcer 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 the 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, or 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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Ask a doctor before use

Ask 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 ulcer 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 the 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, or 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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Inactive ingredients

Acrylate adhesive, polyester, silicone adhesive

Questions?

1-877-748-1970

Forms and strengths

From the FDA NDC Directory · 3 product codes

Dosage formStrengthRouteNDCs
Patch7 mgtransdermal1
Patch14 mgtransdermal1
Patch21 mgtransdermal1

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

1 FDA label

  • Medline Industries, LPShown hereANDA074611 · Label 11/04/2025 · NDC 53329-191, 53329-193, 53329-192Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Medline: common questions

What is Medline used for?
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Medline a prescription drug?
No. Medline is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Medline?
Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
Who makes Medline?
Medline Industries, LP lists Medline with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/04/2025 · Label text is shown as published by the manufacturer. Not medical advice