Regulatory PathRegulatory requirements compared

Active substance

Tetracaine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MINIMS TETRACAINE HCL 1%1 %Eye drops, solution · Ophthalmic use20 Single Dose ContainerSAR 60.05NCE · PrescriptionCHAUVIN BAUSCH & LOMBValid
MINIMS TETRACAINE HCL 0.5%0.5 %Eye drops, solution · Ocular use20 Single Dose ContainerSAR 25.10NCE · PrescriptionCHAUVIN BAUSCH & LOMBWithdrawn by MAH · Not Marketed
TETRACAINE DROPS0.5 %Eye drops · Ocular use1 Dropper ContainerSAR 17.70NCE · PrescriptionALCON COUVREURWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
TETRACAINE HYDROCHLORIDE0.5%solution · ophthalmicALCON LABSPrescription29 Feb 2016
TETRACAINE HYDROCHLORIDE0.5%solution · ophthalmicBAUSCH LOMB IRELANDPrescription12 Mar 2019
TETRACAINE HYDROCHLORIDE0.5%solution · ophthalmicSOMERSET THERAPS LLCPrescription20 Dec 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AMETOP GEL 4%0223057540 MG / GGEL · TOPICALVALEO PHARMA INC
MINIMS TETRACAINE HYDROCHLORIDE021485280.5 % / W/VDROPS · OPHTHALMICBAUSCH & LOMB INC
MINIMS TETRACAINE HYDROCHLORIDE021485441 % / W/VDROPS · OPHTHALMICBAUSCH & LOMB INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTETRACAINE 0.5% EYE DROP$4.32983per ML23 Sep 2026
NHS Drug TariffTetracaine 0.5% eye drops 0.5ml unit dose preservative free£12.4320 unit dose1 Oct 2026
NHS Drug TariffTetracaine 1% eye drops 0.5ml unit dose preservative free£12.4320 unit dose1 Oct 2026
NHS Drug TariffTetracaine 4% gel£1.201.5 gram1 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)

  • 21.3. Ophthalmological preparations > Local anaesthetics · core
    Local anaesthetics
    Local > Ophthalmological > Solution (eye drops): 0.5% (hydrochloride)

Safety signals and safety-related labeling changes

All safety entries for tetracaine →

Combinations containing Tetracaine

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.