NICORETTE

The listing

NDC product code

0135-1500 (labeller 0135, product 1500)

Labeller

Haleon US Holdings LLC

Brand name

NICORETTE

Generic name

nicotine polacrilex

Dosage form

Lozenge

Route

oral

Marketing category

NDA NDA022360

Marketing start

1 June 2022

Listing expires

31 December 2026

Pharmacologic class

Cholinergic Nicotinic Agonist [EPC]

RxNorm concept

359817

Active ingredients

Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.

What the label claims

These are read from this product's own label, not assigned by us and not inferred from the ingredient.

Stated purposeStop smoking aid

Stated useQuitting smoking

Drug Facts, as filed

Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.

Active ingredient

(in each lozenge) (2 mg) Nicotine polacrilex, 2 mg Active ingredient (in each lozenge) (4 mg) Nicotine polacrilex, 4 mg

Purpose

Stop smoking aid

Uses

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

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. • 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. Stop use and ask a doctor if • mouth problems occur • persistent indigestion or severe sore throat occurs • 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...

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. • 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.

Stop use and ask a doctor if

• mouth problems occur • persistent indigestion or severe sore throat occurs • 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)

If pregnant or breast-feeding

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. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

(2 mg Lozenge) • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User's Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day...

Inactive ingredients

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum

Other information

or comments? call toll-free 1-888-569-1743

Label version 4, effective 25 April 2025. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.

Identical on the active ingredient

162 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 52 different labellers. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.

Showing the first 40 of 162. The rest are reachable from each ingredient page.

Sources for this page

• FDA National Drug Code Directory entry for 0135-1500
• DailyMed label, set id c7f32ab1-f6bd-46f5-9852-8eb5b78a3326
• How Lozenges builds these pages