Active ingredient
Nicotine
766 finished FDA listings contain Nicotine as their only active ingredient; 15 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NICOTINE
- Dosage forms
- Film, Extended Release, Gum, Chewing, Lotion, Lozenge, Patch, Patch, Extended Release, Pellet, Spray, Metered
- Routes
- Buccal, Cutaneous, Nasal, Oral, Topical, Transdermal
- Manufacturers / labelers
- 96
- Strengths listed
- .8 mg/100mg · 1.6 mg/100mg · 10 mg/ml · 14 mg/1 · 14 mg/1001 · 14 mg/14mg · 14 mg/24h · 14 mg/g · 2 mg/1 · 2.4 mg/100mg · 200 [kp_c]/200[kp_c] · 21 mg/1 · 21 mg/1001 · 21 mg/21mg · 21 mg/24h · 21 mg/g · 28 mg/1 · 28 mg/1001 · 28 mg/28mg · 3 mg/1001 · 30 [hp_c]/30[hp_c] · 4 mg/1 · 4 mg/1000mg · 42 mg/42mg · 7 mg/1 · 7 mg/1001 · 7 mg/24h · 7 mg/7mg · 7 mg/g
- Brand names in FDA listings (first 80 of 136, A–Z)
- Amazon Basic Care Nicotine Polacrilex, Basic Care Nicotine, Berkley And Jensen Nicotine, Berkley And Jensen Nicotine Polacrilex, Blip, Care One Nicotine, Careone Mini Nicotine Polacrilex, Careone Nicotine, Coated Nicotine, Dg Health Nicotine, Elsophie Nicotine Patches Quit, Equate Nicotine, Euqate Nicotine, Exchange Select Nicotine, Foster And Thrive Nicotine, Foster And Thrive Step 1, Foster And Thrive Step 2, Foster And Thrive Step 3, Good Sense, Good Sense Nicotine, Guhio Nicotine Patch, Habitrol Lozenge Cherry, Habitrol Lozenge Original Flavor, Habitrol Nicotine Polacrilex 2 Mg Coated Cinnamon, Habitrol Nicotine Polacrilex 4 Mg Coated Cinnamon, Habitrol Nicotine Polacrilex Gum 2 Mg Coated Fruit, Habitrol Nicotine Polacrilex Gum 2 Mg Coated Mint, Habitrol Nicotine Polacrilex Gum 4 Mg Coated Fruit, Habitrol Nicotine Polacrilex Gum 4 Mg Coated Mint, Habitrol Nicotine Polacrilex Lozenge Mint, Habitrol Step 1, Habitrol Step 2, Habitrol Step 3, Heb Nicotine, Hqlsey Quit Smoking Patches, Kirkland Signature Nicotine, Kirkland Signature Quit 2, Kirkland Signature Quit 4, Maxi Nicotine, Medline, Members Mark Mini Nicotine, Members Mark Nicotine, Mini Nicotine, Nicduic Quit Smoking Nicotine Patches, Nicduic Quit Smoking Nicotine Patches 1 Step, Nicduic Quit Smoking Nicotine Patches 1-3 Step, Nicduic Quit Smoking Nicotine Patches 2 Step, Nicduic Quit Smoking Nicotine Patches 3 Step, Nicoderm Cq, Nicorette, Nicorette 4mg Cinnamon Surge, Nicorette 4mg Fruit Chill Gum, Lil Drug Store, Nicorette 4mg White Ice Mint Gum, Lil Drug Store, Nicorette Cherry Peppermint, Nicorette Cinnamon Surge, Nicorette Fruit Chill, Nicorette Fruit Chill Nicotine Polacrilex, Nicorette Mint, Nicorette Original, Nicorette Peppermint, Nicorette Spearmint Burst, Nicorette White Ice Mint, Nicorette White Mint Nicotine Polacrilex, Nicotine, Nicotine Coated, Nicotine Gum, Nicotine Lozenge, Nicotine Mini, Nicotine Patch, Nicotine Polacrilex, Nicotine Polacrilex Coated Cinnamon, Nicotine Polacrilex Coated Fruit, Nicotine Polacrilex Coated Ice Mint, Nicotine Polacrilex Coated Mint, Nicotine Polacrilex Gum, Nicotine Polacrilex Mint, Nicotine Polacrilex Origianl Flavor, Nicotine Polacrilex Original, Nicotine Polacrilex Original Flavor, Nicotine Polacrilex, Original
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7407
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018612 | HALEON US HOLDINGS | 1984-01-13 | 6 |
| NDA 020165 | CHATTEM SANOFI | 1991-11-07 | 10 |
| NDA 020076 | DR REDDYS LABS SA | 1991-11-27 | 44 |
| NDA 020066 | HALEON US HOLDINGS | 1992-06-08 | 12 |
| ANDA 074612 | DIFGEN PHARMS | 1997-10-20 | 47 |
| ANDA 074507 | P AND L | 1999-03-15 | 11 |
| ANDA 074707 | P AND L | 1999-03-19 | 11 |
| NDA 021330 | HALEON US HOLDINGS | 2002-10-31 | 4 |
| ANDA 076568 | P AND L | 2004-07-29 | 4 |
| ANDA 076569 | P AND L | 2004-07-29 | 6 |
| ANDA 076777 | L PERRIGO CO | 2004-09-16 | 11 |
| ANDA 076775 | L PERRIGO CO | 2004-09-16 | 15 |
| ANDA 076789 | L PERRIGO CO | 2004-09-16 | 15 |
| ANDA 076779 | L PERRIGO CO | 2004-09-16 | 13 |
| ANDA 077007 | PERRIGO R AND D | 2006-01-31 | 87 |
| ANDA 078546 | PERRIGO R AND D | 2007-05-24 | 6 |
| ANDA 078547 | PERRIGO R AND D | 2007-05-24 | 6 |
| ANDA 078699 | P AND L | 2008-12-29 | 14 |
| ANDA 078697 | P AND L | 2008-12-29 | 16 |
| NDA 022360 | HALEON US HOLDINGS | 2009-05-18 | 7 |
| ANDA 079038 | P AND L | 2009-07-08 | 10 |
| ANDA 079044 | P AND L | 2009-07-08 | 9 |
| ANDA 079219 | P AND L | 2009-07-08 | 7 |
| ANDA 079216 | P AND L | 2009-07-08 | 7 |
| ANDA 090821 | PERRIGO R AND D | 2009-07-10 | 12 |
| ANDA 090711 | PPI-DAC | 2009-07-10 | 29 |
| ANDA 203690 | PPI-DAC | 2012-10-09 | 87 |
| ANDA 204833 | P AND L | 2016-02-26 | 7 |
| ANDA 204794 | P AND L | 2016-05-10 | 5 |
| ANDA 206394 | PERRIGO R AND D | 2016-12-15 | 44 |
| ANDA 206393 | PERRIGO R AND D | 2016-12-15 | 49 |
| ANDA 209206 | P AND L | 2018-06-26 | 11 |
| ANDA 207868 | PLD ACQUISITIONS | 2019-02-07 | 28 |
| ANDA 212056 | P AND L | 2019-07-26 | 3 |
| ANDA 210711 | P AND L | 2019-10-31 | 10 |
| ANDA 212796 | DR REDDYS LABS SA | 2020-01-08 | 6 |
| ANDA 212983 | DR REDDYS LABS SA | 2020-02-21 | 4 |
| ANDA 213233 | DR REDDYS LABS SA | 2020-08-04 | 4 |
| ANDA 213266 | AUROBINDO PHARMA | 2021-08-03 | 8 |
| ANDA 215357 | AUROBINDO PHARMA LTD | 2022-05-13 | 8 |
Showing 40 of 49 applications.
Official labeling on DailyMed
- NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-11
- NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-10
- NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION] · version 3 · 2026-09-10
- NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION] · version 3 · 2026-09-10
- GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY] · version 12 · 2026-09-10
- NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-10
- QUITINE NICOTINE (NICOTINE POLACRILEX) LOZENGE [QUITINE LLC] · version 2 · 2026-09-10
- NICOTINE (NICOTINE POLACRILEX) LOZENGE [SIXARP, LLC] · version 1 · 2026-09-07
- NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.] · version 11 · 2026-09-07
- NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.] · version 9 · 2026-09-07
- NICOTINE (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.] · version 9 · 2026-09-07
- NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-07
Showing the 12 most recent of 622 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.