Data / Drug companies / Nicotine
Nicotine: 37 companies and 103 products in the FDA NDC directory
Nicotine is listed in the FDA National Drug Code Directory by 37 companies, with 103 products in commercial distribution. 27 of the products (26.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are patch, extended release; patch; lozenge, and the newest product started marketing on November 2, 2026.
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- Companies listing it
- 37
- Products
- 103
- Generic (ANDA) products
- 27 (26.2%)
- Application numbers
- 15
- Routes
- Transdermal, Oral, Topical, Nasal
- Brand names
- Nicoderm CQ, Medline, Quit Smoking Patches, Nicotrol, Nicotinum, Nicotinum, Quit Smoking Proven Patches
- openFDA record search
- api.fda.gov
Companies that list nicotine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| H E B | 8 | lozenge; gum, chewing | Generic drugs (ANDA) | May 10, 2019 |
| Rugby Laboratories | 6 | patch, extended release; patch | New drug applications (NDA) | June 25, 2024 |
| A-S Medication Solutions | 5 | patch; patch, extended release | Generic drugs (ANDA) | June 25, 2024 |
| Guangxi Keyun E-commerce Co., Ltd. | 5 | patch | Over the counter monograph drugs | March 20, 2026 |
| Dr. Reddy's Laboratories Inc. | 4 | patch, extended release; kit | New drug applications (NDA) | May 14, 2015 |
| Rite Aid Corporation | 4 | patch, extended release; kit | New drug applications (NDA) | March 31, 2021 |
| Shenzhen Shandian Jingling Technology Co., Ltd. | 4 | patch | Over the counter monograph drugs | November 2, 2026 |
| Strategic Sourcing Services LLC | 4 | patch, extended release; patch | New drug applications (NDA) | December 4, 2017 |
| Amerisource Bergen | 3 | patch, extended release | New drug applications (NDA) | July 1, 2026 |
| CVS Pharmacy | 3 | patch, extended release | New drug applications (NDA) | August 6, 2015 |
| Cardinal Health 110, LLC. DBA Leader | 3 | patch, extended release | New drug applications (NDA) | March 20, 2026 |
| Exelan Pharmaceuticals Inc. | 3 | film, extended release | Generic drugs (ANDA) | October 13, 2025 |
| Golden State Medical Supply, Inc. | 3 | patch, extended release | New drug applications (NDA) | November 12, 1999 |
| Guangzhou Yunzhen Trading Co., Ltd. | 3 | patch | Over the counter monograph drugs | May 20, 2026 |
| Haleon US Holdings LLC | 3 | patch, extended release | New drug applications (NDA) | May 12, 2011 |
| Medline Industries, LP | 3 | patch | Generic drugs (ANDA) | June 30, 2022 |
| Meijer, Inc. | 3 | patch | Generic drugs (ANDA) | March 20, 2024 |
| Target Corporation | 3 | patch, extended release | New drug applications (NDA) | February 16, 2000 |
| The Kroger Co. | 3 | patch, extended release | New drug applications (NDA) | August 25, 2015 |
| Topco Associates LLC | 3 | patch, extended release | New drug applications (NDA) | September 1, 2026 |
| Wal-Mart Stores Inc | 3 | patch, extended release | Authorized generics (NDA) | October 19, 2010 |
| Walgreen Company | 3 | patch, extended release | New drug applications (NDA) | September 1, 2015 |
| Yitongbada (shenzhen) International Trade Co., LTD | 3 | patch | Other unapproved drugs | January 1, 2026 |
| Boiron | 2 | pellet | Unapproved homeopathic products | January 1, 2025 |
| Chain Drug Marketing Association | 2 | patch, extended release | New drug applications (NDA) | October 31, 2020 |
| Costco Wholesale Company | 2 | lozenge | Generic drugs (ANDA) | May 8, 2020 |
| Lil' Drug Store Products, Inc. | 2 | gum, chewing | New drug applications (NDA) | September 14, 2009 |
| CVS Pharmacy | 1 | lozenge | Generic drugs (ANDA) | February 4, 2020 |
| Dolgencorp, Inc. (dollar General & Rexall) | 1 | patch, extended release | New drug applications (NDA) | June 15, 2019 |
| Dongkou County Hecheng Network Technology Co., Ltd. | 1 | patch | Over the counter monograph drugs | December 2, 2025 |
| Dr. Reddy's Laboratories Inc. | 1 | kit | New drug applications (NDA) | May 14, 2015 |
| Guangzhou Ouruisi Biotechnology Co., Ltd | 1 | patch | Over the counter monograph drugs | November 17, 2025 |
| Henan Jiugao Cross-border Ecommerce Co., Ltd. | 1 | patch | Over the counter monograph drugs | October 9, 2025 |
| Jiashen International Trade Limited | 1 | patch | Over the counter monograph drugs | May 17, 2025 |
| Nanjing Ludejin Corporation Management Co., Ltd | 1 | patch | Over the counter monograph drugs | October 15, 2025 |
| Pharmacia & Upjohn Company LLC | 1 | spray, metered | New drug applications (NDA) | May 22, 1996 |
| Sam's West Inc | 1 | patch, extended release | New drug applications (NDA) | March 2, 2012 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Patch, extended release | 48 | 46.6% |
| Patch | 33 | 32% |
| Lozenge | 8 | 7.8% |
| Gum, chewing | 5 | 4.9% |
| Film, extended release | 3 | 2.9% |
| Kit | 3 | 2.9% |
| Pellet | 2 | 1.9% |
| Spray, metered | 1 | 1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 51 | 49.5% |
| Generic drugs (ANDA) | 27 | 26.2% |
| Over the counter monograph drugs | 17 | 16.5% |
| Authorized generics (NDA) | 3 | 2.9% |
| Other unapproved drugs | 3 | 2.9% |
| Unapproved homeopathic products | 2 | 1.9% |
Pharmacologic classes
| Class | Products |
|---|---|
| Cholinergic Nicotinic Agonist | 100 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.