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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.

ApplicationSponsorOriginal approvalListings
NDA 018612HALEON US HOLDINGS1984-01-136
NDA 020165CHATTEM SANOFI1991-11-0710
NDA 020076DR REDDYS LABS SA1991-11-2744
NDA 020066HALEON US HOLDINGS1992-06-0812
ANDA 074612DIFGEN PHARMS1997-10-2047
ANDA 074507P AND L1999-03-1511
ANDA 074707P AND L1999-03-1911
NDA 021330HALEON US HOLDINGS2002-10-314
ANDA 076568P AND L2004-07-294
ANDA 076569P AND L2004-07-296
ANDA 076777L PERRIGO CO2004-09-1611
ANDA 076775L PERRIGO CO2004-09-1615
ANDA 076789L PERRIGO CO2004-09-1615
ANDA 076779L PERRIGO CO2004-09-1613
ANDA 077007PERRIGO R AND D2006-01-3187
ANDA 078546PERRIGO R AND D2007-05-246
ANDA 078547PERRIGO R AND D2007-05-246
ANDA 078699P AND L2008-12-2914
ANDA 078697P AND L2008-12-2916
NDA 022360HALEON US HOLDINGS2009-05-187
ANDA 079038P AND L2009-07-0810
ANDA 079044P AND L2009-07-089
ANDA 079219P AND L2009-07-087
ANDA 079216P AND L2009-07-087
ANDA 090821PERRIGO R AND D2009-07-1012
ANDA 090711PPI-DAC2009-07-1029
ANDA 203690PPI-DAC2012-10-0987
ANDA 204833P AND L2016-02-267
ANDA 204794P AND L2016-05-105
ANDA 206394PERRIGO R AND D2016-12-1544
ANDA 206393PERRIGO R AND D2016-12-1549
ANDA 209206P AND L2018-06-2611
ANDA 207868PLD ACQUISITIONS2019-02-0728
ANDA 212056P AND L2019-07-263
ANDA 210711P AND L2019-10-3110
ANDA 212796DR REDDYS LABS SA2020-01-086
ANDA 212983DR REDDYS LABS SA2020-02-214
ANDA 213233DR REDDYS LABS SA2020-08-044
ANDA 213266AUROBINDO PHARMA2021-08-038
ANDA 215357AUROBINDO PHARMA LTD2022-05-138

Showing 40 of 49 applications.

Official labeling on DailyMed

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.