Regulatory PathRegulatory requirements compared

Active substance

Nicotine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Lexcotinz2 mgLozenge · Oral use24 BottleSAR 16.30Generic · PrescriptionAurobindo Pharma LimitedValid
NICOTINELL TTS-1017.5 mgTransdermal patch · Topical7 BoxSAR 66.10NCE · OTCHaleon Schweiz AGValid
NICOTINELL TTS-2035 mgTransdermal patch · Topical7 BoxSAR 66.10NCE · OTCHaleon Schweiz AGValid
NICOTINELL TTS-3052.5 mgTransdermal patch · Topical7 BoxSAR 66.10NCE · OTCHaleon Schweiz AGValid
Nicorette25 mgTransdermal patch · Transdermal use7 PatchSAR 60.10NCE · OTCMCNEIL PRODUCTS LIMITEDValid
Nicorette15 mgTransdermal patch · Transdermal use7 PatchSAR 60.10NCE · OTCMCNEIL PRODUCTS LIMITEDValid
Nicorette10 mgTransdermal patch · Transdermal use7 PatchSAR 60.10NCE · OTCMCNEIL PRODUCTS LIMITEDValid
Nicorette Freshmint Gum4 mgMedicated chewing-gum · Oral use30 BlisterSAR 36.45NCE · OTCMcNeil Sweden ABValid
Nicorette Freshmint Gum2 mgMedicated chewing-gum · Oral use30 BlisterSAR 28.30NCE · OTCMcNeil Sweden ABValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
NICODERM CQ21MG/24HR; 14MG/24HR; 7MG/24HRfilm, extended release · transdermalCHATTEM SANOFIOver-the-counter7 Nov 1991
HABITROL7MG/24HR; 14MG/24HR; 21MG/24HRfilm, extended release · transdermalDR REDDYS LABS SAOver-the-counter27 Nov 1991
NICOTROL0.5MG/SPRAYspray, metered · nasalPFIZER INCPrescription22 Mar 1996
NICOTINE21MG/24HR; 7MG/24HR; 14MG/24HRfilm, extended release · transdermalDIFGEN PHARMSOver-the-counter20 Oct 1997
HABITROL7MG/24HR; 14MG/24HR; 21MG/24HRfilm, extended release · transdermalDR REDDYS LABS SADiscontinued27 Nov 1991
PROSTEP11MG/24HR; 22MG/24HRfilm, extended release · transdermalAVEVADiscontinued28 Jan 1992
NICOTROL15MG/16HRfilm, extended release · transdermalMCNEIL CONSDiscontinued3 Jul 1996
NICOTROL4MG/CARTRIDGEinhalant · oralPFIZERDiscontinued2 May 1997

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFT NICOTINE 14 MG/24HR PATCH$1.85466per EA23 Sep 2026
US NADACFT NICOTINE 2 MG CHEWING GUM$0.23281per EA23 Sep 2026
US NADACFT NICOTINE 2 MG LOZENGE$0.34675per EA23 Sep 2026
US NADACFT NICOTINE 2 MG MINI LOZENGE$0.3742per EA23 Sep 2026
US NADACFT NICOTINE 21 MG/24HR PATCH$1.87251per EA23 Sep 2026
US NADACFT NICOTINE 4 MG CHEWING GUM$0.28661per EA23 Sep 2026
US NADACFT NICOTINE 4 MG LOZENGE$0.34431per EA23 Sep 2026
US NADACFT NICOTINE 4 MG MINI LOZENGE$0.38851per EA23 Sep 2026
US NADACFT NICOTINE 7 MG/24HR PATCH$1.81971per EA23 Sep 2026
US NADACGNP NICOTINE 2 MG CHEWING GUM$0.23281per EA23 Sep 2026
US NADACGNP NICOTINE 2 MG LOZENGE$0.34675per EA23 Sep 2026
US NADACGNP NICOTINE 2 MG MINI LOZENGE$0.3742per EA23 Sep 2026
NHS Drug TariffNicotine 10mg/16hours transdermal patches£11.857 patch1 Oct 2026
NHS Drug TariffNicotine 14mg/24hours transdermal patches£10.827 patch1 Oct 2026
NHS Drug TariffNicotine 15mg inhalation cartridges with device£7.424 cartridge1 Oct 2026
NHS Drug TariffNicotine 15mg inhalation cartridges with device£26.5820 cartridge1 Oct 2026
NHS Drug TariffNicotine 15mg inhalation cartridges with device£41.2536 cartridge1 Oct 2026
NHS Drug TariffNicotine 15mg/16hours transdermal patches£11.857 patch1 Oct 2026
NHS Drug TariffNicotine 1mg/dose oromucosal spray sugar free£15.5713.2 ml1 Oct 2026
NHS Drug TariffNicotine 21mg/24hours transdermal patches£11.487 patch1 Oct 2026
NHS Drug TariffNicotine 25mg/16hours transdermal patches£11.857 patch1 Oct 2026
NHS Drug TariffNicotine 2mg lozenges sugar free£7.0140 lozenge1 Oct 2026
NHS Drug TariffNicotine 2mg lozenges sugar free£7.4072 lozenge1 Oct 2026
NHS Drug TariffNicotine 2mg lozenges sugar free£12.0580 lozenge1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for nicotine →

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.