Is Nicotine Polacrilex a prescription drug?

No. Nicotine Polacrilex is sold over the counter (OTC) without a prescription.

Are there other products with the same active ingredient as Nicotine Polacrilex?

Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Mini Nicotine, Nicotine Transdermal System.

Who makes Nicotine Polacrilex?

12 manufacturers list Nicotine Polacrilex with the FDA, including Padagis Israel Pharmaceuticals Ltd, AAFES/Your Military Exchanges, AmerisourceBergen (Good Neighbor Pharmacy) 46122.

Checked Oct 26, 2026

OTC

Nicotine Polacrilex

Nicotine Polacrilex is a cholinergic nicotinic agonist (over-the-counter), made by 12 manufacturers.

Type: Over the counter
Drug class: Cholinergic Nicotinic Agonist
Route: Buccal, Oral
Manufacturers: 12; + 9 repackager labels

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

Drug facts

Name: Nicotine Polacrilex
Active ingredients: Nicotine
Drug class: Cholinergic Nicotinic Agonist
Dosage forms: Gum, chewing, Lozenge
Label holder: Padagis Israel Pharmaceuticals Ltd
FDA application: ANDA203690
Label updated: 08/27/2026

Active ingredients

(in each lozenge) Nicotine polacrilex, 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. 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 more than 30 minutes after waking up, use 2 mg nicotine lozenge
If you smoke your first cigarette within 30 minutes of waking up, use 4 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 for the first 6 weeks
Do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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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 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 children and pets.

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

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 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)

Pregnancy or breastfeeding

Keep out of reach of children

And pets.

Other information

Store at 20-25°C (68-77°F)
Keep vial tightly closed and protect from light

Inactive ingredients

Acesulfame potassium, calcium polycarbophil, magnesium stearate, mannitol, natural and artificial mint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum

Questions?

Call toll-free 1-866-751-9303

Forms and strengths

From the FDA NDC Directory · 45 product codes

Dosage form	Strength	Route	NDCs
Gum, chewing	2 mg	buccal	12
Gum, chewing	4 mg	buccal	14
Lozenge	2 mg	oral	9
Lozenge	4 mg	oral	10

What pharmacies pay

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

All prices

Pharmacies paid about $0.240 to $0.371 per tablet, capsule or unit across 14 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.

Manufacturers and labels

39 FDA labels · 9 from repackagers

Padagis Israel Pharmaceuticals LtdShown hereANDA203690 · Label 08/27/2026 · NDC 45802-957Full label
AAFES/Your Military ExchangesANDA079044 · Label 01/16/2026 · NDC 55301-503, 55301-504Full label
AAFES/Your Military ExchangesANDA078699 · Label 05/08/2025 · NDC 55301-428, 55301-429Full label
AmerisourceBergen (Good Neighbor Pharmacy) 46122ANDA076568 · Label 03/18/2026 · NDC 46122-720Full label
AmerisourceBergen (Good Neighbor Pharmacy) 46122ANDA078697 · Label 03/18/2026 · NDC 46122-718Full label
AmerisourceBergen (Good Neighbor Pharmacy) 46122ANDA076568 · Label 03/18/2026 · NDC 46122-725Full label
Chain Drug Consortium, LLCANDA204794 · Label 03/26/2026 · NDC 68016-292, 68016-293Full label
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDA204833 · Label 02/11/2026 · NDC 55910-933Full label
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDA078697 · Label 04/03/2025 · NDC 55910-976Full label
Dr. Reddy's Laboratories Inc.ANDA212983 · Label 07/09/2026 · NDC 43598-484, 43598-485Full label
Dr. Reddy's Laboratories Inc.ANDA213233 · Label 07/09/2026 · NDC 43598-488, 43598-489Full label
Dr. Reddy's Laboratories Inc.ANDA212796 · Label 07/09/2026 · NDC 43598-486, 43598-487Full label
Family Dollar (FAMILY WELLNESS)ANDA204833 · Label 03/18/2026 · NDC 55319-966Full label
Lucy Goods, Inc.ANDA079044 · Label 07/29/2025 · NDC 72224-925Full label
Lucy Goods, Inc.ANDA079216 · Label 07/18/2025 · NDC 72224-924Full label
Lucy Goods, Inc.ANDA078697 · Label 04/29/2025 · NDC 72224-933Full label
Lucy Goods, Inc.ANDA078699 · Label 04/28/2025 · NDC 72224-927Full label
Padagis Israel Pharmaceuticals LtdANDA203690 · Label 04/30/2026 · NDC 45802-089Full label
Padagis Israel Pharmaceuticals LtdANDA077007 · Label 10/07/2025 · NDC 45802-873Full label
Padagis Israel Pharmaceuticals LtdANDA077007 · Label 01/14/2025 · NDC 45802-344Full label
Quitine LLCANDA078697 · Label 12/17/2024 · NDC 84720-933Full label
Quitine LLCANDA078699 · Label 12/17/2024 · NDC 84720-927Full label
Rising Pharma Holdings, Inc.ANDA078699 · Label 12/06/2025 · NDC 57237-322Full label
Rising Pharma Holdings, Inc.ANDA078697 · Label 12/06/2025 · NDC 57237-323Full label
Rite Aid CorporationANDA079216 · Label 08/07/2025 · NDC 11822-2331Full label
WalgreensANDA078697 · Label 03/25/2026 · NDC 0363-9330Full label
WalgreensANDA078699 · Label 03/12/2026 · NDC 0363-9270Full label
WalgreensANDA204794 · Label 02/10/2026 · NDC 0363-9260Full label
WalgreensANDA079216 · Label 02/10/2026 · NDC 0363-9240Full label
WalgreensANDA204833 · Label 02/04/2026 · NDC 0363-3290Full label

Repackager labels (9)

A-S Medication Solutions12/09/2023
A-S Medication Solutions12/09/2023
Bryant Ranch Prepack08/27/2026
Bryant Ranch Prepack08/27/2026
Bryant Ranch Prepack07/29/2025
Bryant Ranch Prepack07/29/2025
Bryant Ranch Prepack04/03/2025
Bryant Ranch Prepack04/03/2025
NuCare Pharmaceuticals, Inc.01/27/2026

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Nicotine Polacrilex: common questions

What is Nicotine Polacrilex used for?: • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Nicotine Polacrilex a prescription drug?: No. Nicotine Polacrilex is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Nicotine Polacrilex?: Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Mini Nicotine, Nicotine Transdermal System.
Who makes Nicotine Polacrilex?: 12 manufacturers list Nicotine Polacrilex with the FDA, including Padagis Israel Pharmaceuticals Ltd, AAFES/Your Military Exchanges, AmerisourceBergen (Good Neighbor Pharmacy) 46122.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/27/2026 · Label text is shown as published by the manufacturer. Not medical advice