Nicotine

Overview

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Indication

For the relief of nicotine withdrawal symptoms and as an aid to smoking cessation.

Associated Conditions

Withdrawal Nicotine

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Acute Effects of Oral Nicotine Pouches	2025/08/18	NCT07128329	Not Applicable	Not yet recruiting	Johns Hopkins University
Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences	2025/08/08	NCT07111234	Not Applicable	Not yet recruiting	Ohio State University Comprehensive Cancer Center
Studying the Effects of Nicotine Concentration and Flavor on Alcohol Use in Young Adults	2025/07/31	NCT07095140	Not Applicable	Not yet recruiting	Ohio State University Comprehensive Cancer Center
PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.	2025/07/31	NCT07095205	Not Applicable	Recruiting	Stony Brook University
Semaglutide for Smoking Cessation in Patients With Diabetes	2025/07/10	NCT07059377	Not Applicable	Not yet recruiting	Ottawa Heart Institute Research Corporation
Smart Olfaction App to Reduce Relapse	2025/06/05	NCT07007195	Early Phase 1	Not yet recruiting	University of Houston
Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation	2025/04/16	NCT06931054	Not Applicable	Recruiting	The University of Hong Kong
iCanQuit Smoking Cessation Among Hispanic Adults	2025/02/06	NCT06811038	Phase 3	Not yet recruiting	Fred Hutchinson Cancer Center
Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia	2025/01/08	NCT06763536	Not Applicable	Recruiting	Ohio State University Comprehensive Cancer Center
Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Young Adult Smokers	2024/12/20	NCT06745154	Not Applicable	Completed	Ohio State University Comprehensive Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
HEB Nicotine	H E B	37808-863	ORAL	2 mg in 1 1	5/19/2025
BLIP	Blip Products, Inc.	82966-012	ORAL	2 mg in 1 1	3/17/2025
Nicotine Polacrilex	Dr. Reddy's Laboratories Inc.	43598-487	ORAL	4 mg in 1 1	6/23/2025
Nicotine	Strategic Sourcing Services LLC	70677-0032	TRANSDERMAL	21 mg in 24 h	7/30/2025
Nicotine	Meijer Distribution Inc	41250-424	ORAL	4 mg in 1 1	5/1/2025
nicotine	H E B	37808-739	ORAL	4 mg in 1 1	5/15/2025
topcare nicotine	Topco Associates LLC	36800-269	ORAL	2 mg in 1 1	2/27/2025
AMAZON BASIC CARE NICOTINE POLACRILEX	Amazon.com Services LLC	72288-623	ORAL	2 mg in 1 1	5/2/2025
Berkley and Jensen NICOTINE	BJWC	68391-012	ORAL	2 mg in 1 1	3/17/2025
Nicotine Mini	Rite Aid Corporation	11822-3315	ORAL	2 mg in 1 1	8/20/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NICORETTE QUICKMIST MOUTHSPRAY 1MG/SPRAY	McNeil AB	SIN16567P	SPRAY	1mg/spray	8/8/2022
Nicorette Invisi Transdermal Patch 25mg/16 hours	LTS Lohmann Therapie-Systeme AG	SIN14296P	PATCH, EXTENDED RELEASE	39.37 mg/22.5 sq cm	1/17/2013
SKIIP NICOTINE MINI LOZENGE 2 MG (MINT)	Rubicon Research Private Limited	SIN16895P	LOZENGE	2.00 mg	10/30/2023
NICOTINELL TTS 20 TRANSDERMAL THERAPEUTIC SYSTEM 14 mg/24 hrs	LTS LOHMANN THERAPIE-SYSTEME AG	SIN06527P	PATCH	35 mg/20 sq cm	11/12/1991
Nicorette Invisi Transdermal Patch 15mg/16 hours	LTS Lohmann Therapie-Systeme AG	SIN14295P	PATCH, EXTENDED RELEASE	23.62mg / 13.5 sq cm	1/17/2013
NICOTINELL TTS 10 TRANSDERMAL THERAPEUTIC SYSTEM 7 mg/24 hrs	LTS LOHMANN THERAPIE-SYSTEME AG	SIN06528P	PATCH	17.5 mg/10 sq cm	11/12/1991
SKIIP NICOTINE MINI LOZENGE 4 MG (MINT)	Rubicon Research Private Limited	SIN16971P	LOZENGE	4.00 mg	3/13/2024
NICOTINELL MINT 4MG CHEWING GUM	FERTIN PHARMA A/S (7100)	SIN12570P	GUM, CHEWING	4 mg	7/27/2004
NICOTINELL TTS 30 TRANSDERMAL THERAPEUTIC SYSTEM 21 mg/24 hrs	LTS LOHMANN THERAPIE-SYSTEME AG	SIN06529P	PATCH	52.5 mg/30 sq cm	11/12/1991
Nicorette Icy Mint Medicated Chewing Gum 4mg	McNeil AB	SIN14327P	GUM, CHEWING	4mg	3/12/2013

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
NICOTINELL TTS 10 PAD	N/A	Haleon Hong Kong Limited	N/A	N/A	11/15/1991
NICOTINELL MINT CHEWING GUM 2MG	N/A	Haleon Hong Kong Limited	N/A	N/A	1/29/2001
NICOTINELL FRUIT CHEWING GUM 4MG	N/A	Haleon Hong Kong Limited	N/A	N/A	1/29/2001
NICOTINELL FRUIT CHEWING GUM 2MG	N/A	Haleon Hong Kong Limited	N/A	N/A	1/29/2001
NICOTINELL TTS 30 PAD	N/A	Haleon Hong Kong Limited	N/A	N/A	11/15/1991
NICOTINELL MINT CHEWING GUM 4MG	N/A	Haleon Hong Kong Limited	N/A	N/A	1/29/2001
NICOTINELL TTS 20 PAD	N/A	Haleon Hong Kong Limited	N/A	N/A	11/15/1991

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NICORETTE 16 hr INVISIPATCH nicotine 10 mg/16 hour transdermal patch sachet	162577	Johnson & Johnson Pacific Pty Ltd	Medicine	A	6/18/2009
NICABATE MINI LOZENGES nicotine 4 mg Mint Flavour lozenge tube	156604	Haleon Australia Pty Ltd	Medicine	A	11/10/2008
NICORETTE COOLDROPS nicotine 2 mg (as nicotine polacrilex) lozenge carton	489190	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/19/2025
NICORETTE 16 hr Patch nicotine 10mg/16hr transdermal patch sachet	203285	Johnson & Johnson Pacific Pty Ltd	Medicine	A	11/26/2012
HERRON NICAWAY nicotine 4 mg coated chewing gum mint flavour blister pack	287344	Perrigo Australia Pty Ltd	Medicine	A	3/31/2017
NICORETTE COOLDROPS nicotine 2mg lozenge bottle	205210	Johnson & Johnson Pacific Pty Ltd	Medicine	A	1/24/2013
HERRON NICAWAY STEP 1 PATCH Nicotine 52.5mg transdermal nicotine patch sachet	323699	Perrigo Australia Pty Ltd	Medicine	A	9/17/2019
NICORETTE nicotine 4mg (as nicotine polacrilex) spearmint flavour chewing gum blister pack	329546	Johnson & Johnson Pacific Pty Ltd	Medicine	A	2/6/2020
AMCAL NICOTINE CHEWING GUM 2MG mint flavour blister pack (new label)	229432	Perrigo Australia Pty Ltd	Medicine	A	10/16/2014
NICORETTE QUICKMIST nicotine 1 mg/spray cool berry flavour pump actuated metered dose aerosol	284867	Johnson & Johnson Pacific Pty Ltd	Medicine	A	1/20/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NICORETTE GUM 2MG	merrell dow pharmaceuticals (canada) inc., division of mmdc	00580317	Gum - Oral	2 MG / GUM	12/31/1984
TOBACOPT	terra botanica products ltd.	02233374	Liquid - Oral	12 X	5/25/1998
NICOTINUM	dolisos canada inc.	02234630	Globules , Granules , Liquid - Oral	6 X	1/5/1998
NICODERM TRD 114MG NICOTINE/21	merrell dow pharmaceuticals (canada) inc., division of mmdc	01968106	Patch - Transdermal	114 MG / PAD	12/31/1992
NICORETTE INVISIPATCH	mcneil consumer healthcare division of johnson & johnson inc	02362066	Patch - Transdermal	25 MG / 16 HOUR	N/A
NICODERM TRD 78MG NICOTINE/14	merrell dow pharmaceuticals (canada) inc., division of mmdc	01968114	Patch - Transdermal	78 MG / PAD	12/31/1992
NICORETTE PLUS 4MG	merrell dow pharmaceuticals (canada) inc., division of mmdc	00580325	Gum - Oral	4 MG / GUM	12/31/1984
TABACUM-INJEEL LIQ (12D,30D,200D/1.1ML)	Biologische Heilmittel Heel Gmbh	02065304	Liquid - Oral	12 D / 1.1 ML	12/31/1994
NICODERM TRD 36MG NICOTINE/7 SQCM PATCH	merrell dow pharmaceuticals (canada) inc., division of mmdc	01968122	Patch - Transdermal	36 MG / PAD	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NICOTINELL MINT 1 mg COMPRIMIDOS PARA CHUPAR	Haleon Spain S.A.	63795	COMPRIMIDO PARA CHUPAR	Sin Receta	Commercialized
NICOTINELL COOL MINT 4 mg CHICLE MEDICAMENTOSO	Haleon Spain S.A.	65584	CHICLE MEDICAMENTOSO	Sin Receta	Commercialized
NICORETTE CLEAR 15 MG/16 HORAS PARCHES TRANSDERMICOS	Jntl Consumer Health (Spain) S.L.	75830	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NIQUITIN CLEAR 14 MG/24 HORAS PARCHE TRANSDERMICO	Perrigo Espana S.A.	65841	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NICORETTE BUCOMIST 1 MG/PULSACION SOLUCION PARA PULVERIZACION BUCAL	Jntl Consumer Health (Spain) S.L.	76185	SOLUCIÓN PARA PULVERIZACIÓN BUCAL	Sin Receta	Commercialized
NICOTINELL COOL MINT 2 mg CHICLE MEDICAMENTOSO	Haleon Spain S.A.	65670	CHICLE MEDICAMENTOSO	Sin Receta	Commercialized
NICORETTE CLEAR 10 MG/16 HORAS PARCHES TRANSDERMICOS	Jntl Consumer Health (Spain) S.L.	75829	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NICORETTE BUCOMIST 1 MG/PULSACION SOLUCION PARA PULVERIZACION BUCAL SABOR FRUTA MENTA	Jntl Consumer Health (Spain) S.L.	82520	SOLUCIÓN PARA PULVERIZACIÓN BUCAL	Sin Receta	Commercialized
NICOTINELL 14 MG/24 HORAS PARCHE TRANSDERMICO	Haleon Spain S.A.	68301	PARCHE TRANSDÉRMICO	Sin Receta	Commercialized
NICOTINELL FRUIT 2 mg CHICLE MEDICAMENTOSO	Haleon Spain S.A.	65587	CHICLE MEDICAMENTOSO	Sin Receta	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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