Quick answers
- What is Habitrol?
- Habitrol is a brand name of Nicotine, an over-the-counter medicine. The FDA NDC Directory lists 7 Habitrol products in 5 strengths and forms.
- Who makes Habitrol?
- Dr Reddys Labs Sa holds the FDA application for Habitrol (NDA020076, approved November 27, 1991).
- Is there a generic or store brand of Habitrol?
- Yes. The FDA NDC Directory lists 386 other products with the same active ingredients, strength and form as a Habitrol product, 327 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Habitrol been recalled?
- No recall linked to Habitrol products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Habitrol is
Each Habitrol 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 14 mg/24 h patch, extended release (transdermal) | Habitrol Step 2 | 22 products, 19 companies | DailyMed |
| nicotine 2 mg lozenge (oral) | Habitrol Lozenge Cherry, Habitrol Lozenge Original Flavor | 159 products, 45 companies | DailyMed |
| nicotine 21 mg/24 h patch, extended release (transdermal) | Habitrol Step 1 | 26 products, 22 companies | DailyMed |
| nicotine 4 mg lozenge (oral) | Habitrol Lozenge Cherry, Habitrol Lozenge Original Flavor | 158 products, 48 companies | DailyMed |
| nicotine 7 mg/24 h patch, extended release (transdermal) | Habitrol Step 3 | 21 products, 18 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 |
|---|---|---|---|
| NDA020076 | Dr Reddys Labs Sa | November 27, 1991 | 3 |
| ANDA212983 | Dr Reddys Labs Sa | February 21, 2020 | 2 |
| ANDA213233 | Dr Reddys Labs Sa | August 4, 2020 | 2 |
Companies that list Habitrol
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Habitrol products.
- Dr. Reddy's Laboratories Inc.7 products
Recalls
No recall linked to Habitrol products (by their NDC code or label) appears in the FDA enforcement reports.
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.