Regulatory PathRegulatory requirements compared

Active substance

Minoxidil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALOPEXY 5% topical solution5 %Cutaneous solution · Topical3 BottleSAR 84.25Generic · OTCPIERRE FABRE DERMATOLOGIEValid
ALOPEXY 5% topical solution5 %Cutaneous solution · Topical1 BottleSAR 37.40Generic · OTCPIERRE FABRE DERMATOLOGIEValid
AVOGAIN5 %Cutaneous solution · Topical1 BottleSAR 66.00Generic · OTCMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AVOGAIN2 %Cutaneous solution · Topical1 BottleSAR 55.50Generic · OTCMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
HAIRGAIN 2% W-V SOLUTION FOR WOMEN2 %Solution · Topical1 BottleSAR 57.75Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid
HAIRGAIN 5% W-V SOLUTION FOR MEN5 %Solution · Topical1 BottleSAR 57.75Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid
HAIRGROW5 %Solution · Topical1 BottleSAR 59.05Generic · OTCDAR ALDAWAValid
HAIRGROW2 %Solution · Topical1 BottleSAR 52.70Generic · OTCDAR ALDAWAValid
MINOXIL 5% SOLUTION5 %Cutaneous solution · Topical1 BottleSAR 64.15Generic · OTCDallah Pharma FactoryValid
Minoxil2 %Solution · Topical1 BottleSAR 47.75Generic · OTCDallah Pharma FactoryValid
NEOXIDIL 2% SOLN.2 %Solution · Topical1 BottleSAR 55.30Generic · OTCGALDERMAValid
REGAINE 5% TOPICAL SOLUTION5 %Cutaneous solution · Topical1 BottleSAR 86.35Generic · OTCMCNEIL PRODUCTS LIMITEDValid
REGAINE TOPICAL SOLN 2%2 %Cutaneous solution · Topical1 BottleSAR 67.65NCE · OTCMCNEIL PRODUCTS LIMITEDValid
Regaine Foam for Men 5%5 %Cutaneous foam · Cutaneous use1 AEROSOL CANSAR 95.00NCE · OTCMCNEIL PRODUCTS LIMITEDValid
HAIRAL 2% TOPICAL SOLUTION2 %Solution · Topical1 BottleSAR 31.15Generic · OTCJERASH PHARMACEUTICALS LIMITED COMPANYSuspended · Not Marketed
HAIRAL 5% TOPICAL SOLUTION5 %Solution · Topical1 BottleSAR 31.15Generic · OTCJERASH PHARMACEUTICALS LIMITED COMPANYSuspended · Not Marketed
REGAINE TOPICAL GEL 2%2 %Gel · Topical1 BottleSAR 97.15Generic · PrescriptionPFIZERWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
MINOXIDIL2.5MGtablet · oralWATSON LABSPrescription3 Mar 1987
MINOXIDIL10MGtablet · oralWATSON LABSPrescription3 Mar 1987
ROGAINE (FOR MEN)2%solution · topicalKENVUE BRANDSOver-the-counter17 Aug 1988
ROGAINE (FOR WOMEN)2%solution · topicalKENVUE BRANDSOver-the-counter17 Aug 1988
MINOXIDIL2.5MGtablet · oralPH HEALTHPrescription14 Nov 1988
MINOXIDIL10MGtablet · oralPH HEALTHPrescription14 Nov 1988
MINOXIDIL10MG; 2.5MGtablet · oralSUN PHARM INDUSTRIESPrescription13 Dec 1995
MINOXIDIL (FOR MEN)2%solution · topicalP AND LOver-the-counter5 Apr 1996
MINOXIDIL (FOR MEN)2%solution · topicalAUROBINDO PHARMA LTDOver-the-counter28 Feb 1997
MINOXIDIL (FOR WOMEN)2%solution · topicalAUROBINDO PHARMA LTDOver-the-counter28 Feb 1997
ROGAINE EXTRA STRENGTH (FOR MEN)5%solution · topicalKENVUE BRANDSOver-the-counter14 Nov 1997
MINOXIDIL (FOR MEN)2%solution · topicalL PERRIGO COOver-the-counter30 Jul 1999
MINOXIDIL (FOR WOMEN)2%solution · topicalL PERRIGO COOver-the-counter30 Jul 1999
MINOXIDIL EXTRA STRENGTH (FOR MEN)5%solution · topicalP AND LOver-the-counter17 Nov 2000
MINOXIDIL EXTRA STRENGTH (FOR MEN)5%solution · topicalPERRIGOOver-the-counter13 Jun 2001
MINOXIDIL EXTRA STRENGTH (FOR MEN)5%solution · topicalAUROBINDO PHARMA LTDOver-the-counter27 Feb 2003
THEROXIDIL5%solution · topicalPURE SOURCEOver-the-counter24 Aug 2004
MEN'S ROGAINE5%aerosol, foam · topicalKENVUE BRANDSOver-the-counter20 Jan 2006
WOMEN'S ROGAINE5%aerosol, foam · topicalKENVUE BRANDSOver-the-counter20 Jan 2006
THEROXIDIL2%solution · topicalPURE SOURCEOver-the-counter9 Nov 2007
MINOXIDIL5%aerosol, foam · topicalPERRIGO PHARMA INTLOver-the-counter28 Apr 2011
MINOXIDIL (FOR MEN)5%aerosol, foam · topicalP AND LOver-the-counter17 Feb 2017
MINOXIDIL (FOR WOMEN)5%aerosol, foam · topicalP AND LOver-the-counter17 Feb 2017
MINOXIDIL (FOR MEN)5%aerosol, foam · topicalTAROOver-the-counter31 Dec 2018
MINOXIDIL (FOR WOMEN)5%aerosol, foam · topicalTAROOver-the-counter31 Dec 2018

22 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HAIR REGROWTH FORMULA0235659720 MG / MLSOLUTION · TOPICALVITA HEALTH PRODUCTS INC
LONITEN 10MG0051450010 MGTABLET · ORALPFIZER CANADA ULC
LONITEN 2.5MG005144972.5 MGTABLET · ORALPFIZER CANADA ULC
MEN'S GLN-MINOXIDIL025534655 % / W/WAEROSOL (FOAM) · TOPICALGLENMARK PHARMACEUTICALS CANADA INC.
MEN'S HAIR REGROWTH TREATMENT025514465 % / W/WAEROSOL (FOAM) · TOPICALTARO PHARMACEUTICALS INC
MEN'S ROGAINE0070892520 MG / MLSOLUTION · TOPICALKENVUE CANADA INC.
MEN'S ROGAINE FOAM 5%023686845 % / W/WAEROSOL (FOAM) · TOPICALKENVUE CANADA INC.
WOMEN'S HAIR REGROWTH TREATMENT025516595 % / W/WAEROSOL (FOAM) · TOPICALTARO PHARMACEUTICALS INC
WOMEN'S ROGAINE FOAM 5%024247035 % / W/WAEROSOL (FOAM) · TOPICALKENVUE CANADA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMINOXIDIL 10 MG TABLET$0.15615per EA23 Sep 2026
US NADACMINOXIDIL 2.5 MG TABLET$0.09821per EA23 Sep 2026
US NADACMINOXIDIL 5% SOLUTION$0.30095per ML23 Sep 2026
NHS Drug TariffMinoxidil 10mg tablets£30.6860 tablet1 Oct 2026
NHS Drug TariffMinoxidil 2.5mg tablets£8.8860 tablet1 Oct 2026
NHS Drug TariffMinoxidil 5% foam£25.9460 gram1 Oct 2026
NHS Drug TariffMinoxidil 5% foam£39.71120 gram1 Oct 2026
NHS Drug TariffMinoxidil 5% foam£59.68180 gram1 Oct 2026
NHS Drug TariffMinoxidil 5mg tablets£20.4460 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.

Safety signals and safety-related labeling changes

All safety entries for minoxidil →

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.