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OTC

Nicotine

Nicotine is a cholinergic nicotinic agonist (over-the-counter), made by 4 manufacturers.

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Oral, Transdermal
Manufacturers
4
+ 1 repackager labels

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

Drug facts

Name
Nicotine
Active ingredients
Nicotine
Dosage forms
Gum, chewing, Lozenge, Patch
Label holder
H E B
FDA application
ANDA206393
Label updated
06/25/2026

Active ingredients

(in each chewing piece) Nicotine polacrilex (equal to 4 mg nicotine)

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 important information
  • Begin using the gum on your quit day
  • If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
  • If you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours
  • Nicotine gum is a medicine and must be used a certain way to get the best results
  • Chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
  • Repeat this process until most of the tingle is gone (about 30 minutes)
  • Do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
  • To improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
  • If you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
  • Do not use more than 24 pieces a day
  • It is important to complete treatment. If you feel you need to use the gum 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

  • A sodium-restricted diet
  • Heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • High blood pressure not controlled with medication. Nicotine can increase blood pressure.
  • 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if
  • Mouth, teeth or jaw problems occur
  • Irregular heartbeat or palpitations occur
  • You get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, 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. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask a doctor before use

  • A sodium-restricted diet
  • Heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • High blood pressure not controlled with medication. Nicotine can increase blood pressure.
  • Stomach ulcer or diabetes
  • History of seizures

Ask a doctor or pharmacist before use

  • Using a non-nicotine stop smoking drug
  • Taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor

  • Mouth, teeth or jaw problems occur
  • Irregular heartbeat or palpitations occur
  • You get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, 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. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Inactive ingredients

Acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, gelatin, gum base, mannitol, menthol, natural and artificial mint and peppermint flavors, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sucralose, talc, titanium dioxide, xylitol

Questions?

Call 1-866-677-7858

Forms and strengths

From the FDA NDC Directory · 17 product codes

Dosage formStrengthRouteNDCs
Gum, chewing2 mgoral2
Gum, chewing4 mgoral1
Lozenge2 mgoral2
Lozenge4 mgoral2
Patch7 mg/24htransdermal3
Patch14 mg/24htransdermal3
Patch21 mg/24htransdermal4

What pharmacies pay

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

All prices

Pharmacies paid about $1.90 to $1.99 per tablet, capsule or unit across 8 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

11 FDA labels · 1 from repackagers

  • H E BShown hereANDA206393 · Label 06/25/2026 · NDC 37808-739Full label
  • H E BANDA206394 · Label 06/19/2026 · NDC 37808-711Full label
  • H E BANDA076777 · Label 06/18/2026 · NDC 37808-682Full label
  • H E BANDA203690 · Label 03/03/2026 · NDC 37808-900Full label
  • H E BANDA203690 · Label 03/03/2026 · NDC 37808-707Full label
  • H E BANDA090711 · Label 04/17/2019 · NDC 37808-383Full label
  • H E BANDA090711 · Label 04/16/2019 · NDC 37808-533Full label
  • Meijer, Inc.ANDA074612 · Label 01/22/2026 · NDC 79481-0052, 79481-0053, 79481-0054Full label
  • Rugby LaboratoriesANDA074612 · Label 06/05/2024 · NDC 0536-5894, 0536-5896, 0536-5895Full label
  • Strategic Sourcing Services LLCANDA074612 · Label 07/30/2025 · NDC 70677-0032, 70677-0031, 70677-0030Full label
Repackager labels (1)
  • A-S Medication Solutions05/30/2025

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Nicotine: common questions

What is Nicotine used for?
• reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Nicotine a prescription drug?
No. Nicotine is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Nicotine?
Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
Who makes Nicotine?
4 manufacturers list Nicotine with the FDA, including H E B, Meijer, Inc., Rugby Laboratories.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 06/25/2026 · Label text is shown as published by the manufacturer. Not medical advice