Is Nicotine polacrilex registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Nicotine polacrilex.

Is Nicotine polacrilex approved by the US FDA?

Drugs@FDA lists 60 application product lines for Nicotine polacrilex, including NICORETTE (Over-the-counter); NICORETTE (MINT) (Over-the-counter); NICORETTE (Over-the-counter); NICORETTE (MINT) (Over-the-counter); NICOTINE POLACRILEX (Over-the-counter).

Active substance

Nicotine polacrilex

SFDA 4
US FDA 60

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NIQUITIN 2MG MINT LOZENGE	2 mg	Lozenge · Oral use	24 Bottle	SAR 31.80	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
NIQUITIN 2MG MINT LOZENGE	2 mg	Lozenge · Oral use	48 Bottle	SAR 47.30	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
NIQUITIN 4MG MINT LOZENGE	4 mg	Lozenge · Oral use	24 Bottle	SAR 31.80	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
NIQUITIN 4MG MINT LOZENGE	4 mg	Lozenge · Oral use	48 Bottle	SAR 47.30	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NICORETTE	EQ 2MG BASE	gum, chewing · buccal	HALEON US HOLDINGS	Over-the-counter	13 Jan 1984
NICORETTE (MINT)	EQ 2MG BASE	gum, chewing · buccal	HALEON US HOLDINGS	Over-the-counter	13 Jan 1984
NICORETTE	EQ 4MG BASE	gum, chewing · buccal	HALEON US HOLDINGS	Over-the-counter	8 Jun 1992
NICORETTE (MINT)	EQ 4MG BASE	gum, chewing · buccal	HALEON US HOLDINGS	Over-the-counter	8 Jun 1992
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	15 Mar 1999
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	19 Mar 1999
NICORETTE	EQ 2MG BASE; EQ 4MG BASE	troche/lozenge · oral	HALEON US HOLDINGS	Over-the-counter	31 Oct 2002
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	29 Jul 2004
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	29 Jul 2004
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	L PERRIGO CO	Over-the-counter	16 Sep 2004
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	L PERRIGO CO	Over-the-counter	16 Sep 2004
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	L PERRIGO CO	Over-the-counter	16 Sep 2004
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	L PERRIGO CO	Over-the-counter	16 Sep 2004
NICOTINE POLACRILEX	EQ 2MG BASE; EQ 4MG BASE	troche/lozenge · oral	PERRIGO R AND D	Over-the-counter	31 Jan 2006
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	PERRIGO R AND D	Over-the-counter	30 Oct 2006
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	PERRIGO R AND D	Over-the-counter	30 Oct 2006
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	PERRIGO R AND D	Over-the-counter	24 May 2007
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	PERRIGO R AND D	Over-the-counter	24 May 2007
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	29 Dec 2008
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	29 Dec 2008
NICORETTE	EQ 2MG BASE; EQ 4MG BASE	troche/lozenge · oral	HALEON US HOLDINGS	Over-the-counter	18 May 2009
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	8 Jul 2009
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	8 Jul 2009
NICOTINE POLACRILEX	EQ 2MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	8 Jul 2009
NICOTINE POLACRILEX	EQ 4MG BASE	gum, chewing · buccal	P AND L	Over-the-counter	8 Jul 2009

35 more — full table

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.