Quick answers
- What is Nicorette?
- Nicorette is a brand name of Nicotine, an over-the-counter medicine. The FDA NDC Directory lists 28 Nicorette products in 5 strengths and forms.
- Who makes Nicorette?
- Haleon US Holdings holds the FDA application for Nicorette (NDA018612, approved January 13, 1984). 1 other company (repackagers or distributors) also list Nicorette products.
- Is there a generic or store brand of Nicorette?
- Yes. The FDA NDC Directory lists 738 other products with the same active ingredients, strength and form as a Nicorette product, 732 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Nicorette been recalled?
- FDA enforcement reports list 6 recalls of Nicorette products; the newest started February 20, 2014. A recall usually concerns specific lots, not every product.
What Nicorette is
Each Nicorette product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Nicotine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nicotine 2 mg gum, chewing (oral) | Nicorette Mint, Nicorette White Ice Mint, Nicorette Original, Nicorette Spearmint Burst | 130 products, 40 companies | DailyMed |
| nicotine 2 mg lozenge (oral) | Nicorette, Nicorette Cherry Peppermint, Nicorette Peppermint | 154 products, 44 companies | DailyMed |
| nicotine 4 mg gum, chewing (oral) | Nicorette Spearmint Burst, Nicorette Original, Nicorette Mint, Nicorette Fruit Chill | 150 products, 45 companies | DailyMed |
| nicotine 4 mg gum, chewing (buccal) | Nicorette 4mg Cinnamon Surge | 150 products, 45 companies | DailyMed |
| nicotine 4 mg lozenge (oral) | Nicorette, Nicorette Peppermint, Nicorette Cherry Peppermint | 154 products, 47 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Nicotine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018612 | Haleon US Holdings | January 13, 1984 | 6 |
| NDA020066 | Haleon US Holdings | June 8, 1992 | 9 |
| NDA021330 | Haleon US Holdings | October 31, 2002 | 4 |
| ANDA077007 | Perrigo R and D | January 31, 2006 | 2 |
| NDA022360 | Haleon US Holdings | May 18, 2009 | 7 |
Companies that list Nicorette
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nicorette products.
- Haleon US Holdings LLC26 products
- Lil' Drug Store Products, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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February 20, 2014 · Class III · Terminated · D-1245-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made i — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
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February 20, 2014 · Class III · Terminated · D-1242-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
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February 20, 2014 · Class III · Terminated · D-1243-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
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February 20, 2014 · Class III · Terminated · D-1240-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108 — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
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February 20, 2014 · Class III · Terminated · D-1246-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count N — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
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February 20, 2014 · Class III · Terminated · D-1241-2014
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108 — GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.