Regulatory PathRegulatory requirements compared

Active substance

Proparacaine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALCAIN DROPS 0.5%0.5 %Eye drops · Ocular use1 Dropper ContainerSAR 9.30NCE · PrescriptionALCON LABORATORIESWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
ALCAINE0.5%solution/drops · ophthalmicALCON LABS INCPrescription22 Dec 1971
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicBAUSCH AND LOMB INCPrescription29 Sep 1995
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicRISINGPrescription16 Mar 2000
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicSOMERSET THERAPS LLCPrescription9 Aug 2024
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicMANKIND PHARMAPrescription21 May 2025
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicMICRO LABSPrescription20 Oct 2025
OPHTHAINE0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution/drops · ophthalmicAPOTHECONDiscontinued1 Jul 1953
OPHTHETIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution/drops · ophthalmicALLERGANDiscontinued23 Jan 1961
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicSOLA BARNES HINDDiscontinued1 Nov 1974
PROPARACAINE HYDROCHLORIDE0.5%solution/drops · ophthalmicSOLA BARNES HINDDiscontinued19 Dec 1974
PARACAINE0.5%solution/drops · ophthalmicOPTOPICSDiscontinued5 Aug 1982
KAINAIR0.5%solution/drops · ophthalmicPHARMAFAIRDiscontinued7 Jun 1983

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALCAINE000350760.5 % / W/VDROPS · OPHTHALMICALCON CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPROPARACAINE 0.5% EYE DROPS$1.46978per ML30 Sep 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.

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.