Regulatory PathRegulatory requirements compared

Active substance

Terbinafine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LAMIFEN 1% CREAM1 %Cream · Topical1 BottleSAR 19.50Generic · OTCJamjoom Pharmaceuticals Factory CompanyValid
LAMIFEN 250MG TABLET250 mgTablet · Oral use7 BlisterSAR 34.40Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
LAMIFEN 250MG TABLET250 mgTablet · Oral use14 BottleSAR 68.85Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
LAMISIL 1% CREAM1 %Cream · Topical1 TubeSAR 23.15NCE · OTCGSK CONSUMER HEALTHCARE SCHWEIZ AGValid
LAMISIL 1% SPRAY1 %Spray · Topical1 BottleSAR 43.20NCE · OTCGSK CONSUMER HEALTHCARE SCHWEIZ AGValid
LAMISIL 250 mg tablet250 mgTablet · Oral use14 BlisterSAR 68.85NCE · PrescriptionNOVARTISValid
LAMISIL ONCE 1% CUTANEOUS SOLUTION1 %Solution · Topical1 Spray PumpSAR 26.65NCE · OTCNOVARTISValid
NEGAFEN 1% cream1 %Cream · Topical1 TubeSAR 10.95Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
NEGAFEN 250 mg tablet250 mgTablet · Oral use14 BlisterSAR 68.85Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
TERFINA CREAM1.02 %Cream · Topical1 TubeSAR 10.95Generic · OTCOMAN PHARMACEUTICAL PRODUCTSValid
Xeerun1 %Cutaneous spray, solution · Topical1 Spray ContainerSAR 28.55Generic · OTCAmman Pharmaceutical Industries (API)Valid
LAMISIL 1% SOLUTION1 %Cutaneous solution · Topical1 BottleSAR 42.70NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
LAMISIL 250 mg tablet250 mgTablet · Oral use28 BlisterSAR 137.70NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
LAMISIL DERM 1% GEL1 %Gel · Topical1 TubeSAR 12.15NCE · OTCNOVARTISWithdrawn by MAH · Not Marketed
RIATEBIFINE250 %Cream · Topical14 BlisterSAR 68.85Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIATEBIFINE250 mgTablet · Oral use1 BottleSAR 13.50Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIATEBIFINE250 mgTablet · Oral use7 BlisterSAR 60.10Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIATEBIFINE 1% TOPICAL SOLUTION1 %Cutaneous solution · Topical1 BottleSAR 29.90Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
TERBIN 1% CREAM1 %Cream · Topical1 TubeSAR 5.40Generic · OTCGLOBAL NABIWithdrawn by MAH · Not Marketed
TERFINIL 1% CREAM1 %Cream · Topical1 TubeSAR 12.15Generic · OTCJazeera Pharmaceutical Industries (JPI)Withdrawn by MAH · Not Marketed
TERFINIL 125MG TABLETS125 mgTablet · Oral use14 BlisterSAR 44.25Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
TERFINIL 250MG TABLETS250 mgTablet · Oral use14 BlisterSAR 88.55Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS; LICHEN PLANUS; SEBORRHEIC DERMATITIS; TINEA CORPORIS, TINEA CRURIS, AND TINEA PEDIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
LAMISIL1%cream · topicalKARO HLTHCAREOver-the-counter9 Mar 1999
LAMISIL AT1%solution · topicalKARO HLTHCAREOver-the-counter17 Mar 2000
LAMISIL AT1%spray · topicalKARO HLTHCAREOver-the-counter17 Mar 2000
LAMISIL AT1%gel · topicalKARO HLTHCAREOver-the-counter24 Jul 2006
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralSENORES PHARMSPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralCIPLAPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDE1%cream · topicalSUN PHARMA CANADAOver-the-counter2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralEMED MEDCLPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralGLENMARK PHARMS LTDPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralORBION PHARMSPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralCHARTWELLPrescription2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralAUROBINDO PHARMAPrescription2 Jul 2007
LAMISIL1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · topicalNOVARTISDiscontinued30 Dec 1992
LAMISILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralNOVARTISDiscontinued10 May 1996
LAMISIL1%solution · topicalKARO HLTHCAREDiscontinued17 Oct 1997
LAMISIL1%gel · topicalKARO HLTHCAREDiscontinued29 Apr 1998
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralHERITAGE PHARMA AVETDiscontinued2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralNATCO PHARMADiscontinued2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralINVAGEN PHARMSDiscontinued2 Jul 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralWOCKHARDTDiscontinued2 Jul 2007
LAMISILEQ 125MG BASE/PACKET; EQ 187.5MG BASE/PACKETgranule · oralNOVARTISDiscontinued28 Sep 2007
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralBRECKENRIDGE PHARMDiscontinued4 Jun 2010
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralGEDEON RICHTER USADiscontinued
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralMYLANDiscontinued
TERBINAFINE HYDROCHLORIDEEQ 250MG BASEtablet · oralROXANEDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-TERBINAFINE02239893250 MGTABLET · ORALAPOTEX INC
AURO-TERBINAFINE02320134250 MGTABLET · ORALAURO PHARMA INC
LAMISIL020310941 % / %CREAM · TOPICALNOVARTIS PHARMACEUTICALS CANADA INC
LAMISIL022387031 % / W/WSPRAY · TOPICALNOVARTIS PHARMACEUTICALS CANADA INC
PMS-TERBINAFINE02294273250 MGTABLET · ORALPHARMASCIENCE INC
TERBINAFINE02385279250 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
TERBINAFINE-25002242735250 MGTABLET · ORALPRO DOC LIMITEE
TEVA-TERBINAFINE02254727250 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTERBINAFINE 1% CREAM$0.23063per GM23 Sep 2026
US NADACTERBINAFINE 1% CREAM$0.39833per GM23 Sep 2026
US NADACTERBINAFINE 1% CREAM$0.30853per GM23 Sep 2026
US NADACTERBINAFINE HCL 250 MG TABLET$0.1426per EA23 Sep 2026
NHS Drug TariffTerbinafine 1% cream£1.6215 gram1 Oct 2026
NHS Drug TariffTerbinafine 1% cream£3.2430 gram1 Oct 2026
NHS Drug TariffTerbinafine 1% gel£4.1815 gram1 Oct 2026
NHS Drug TariffTerbinafine 1% solution£6.704 gram1 Oct 2026
NHS Drug TariffTerbinafine 1% spray£4.1815 ml1 Oct 2026
NHS Drug TariffTerbinafine 250mg tablets£1.2014 tablet1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 13.1. Dermatological medicines > Antifungal medicines · core
    Fungal infection of the skin
    Local > Topical > Cream: 1% terbinafine hydrochloride | Local > Topical > Ointment: 1% terbinafine hydrochloride

Safety signals and safety-related labeling changes

  • US FDA 29 Mar 2019 LAMISIL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 29 Mar 2019 LAMISIL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for terbinafine →

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.