Regulatory PathRegulatory requirements compared

Active substances

Ciprofloxacin + Fluocinolone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Cetraxal plus3,0.25 mg/ml,mg/mlEar drops, solution · Auricular use15 Single Dose ContainerSAR 41.30NCE · PrescriptionLaboratories SALVAT, S.AValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
OTOVELEQ 0.3% BASE;0.025%solution/drops · oticLAB SALVATPrescription29 Apr 2016

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
OTIXAL024596550.3 % / W/V; 0.025 % / W/VSOLUTION · OTICMEDEXUS PHARMACEUTICALS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffCiprofloxacin 3mg/ml / Fluocinolone acetonide 0.25mg/ml ear drops 0.25ml unit dose preservative free£6.0115 unit dose1 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.

Components

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.