Active substances
Hydrocortisone + Neomycin + Polymyxin b
- SFDA 1
- US FDA 22
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| OTOSPORIN EAR DROPS | Ear drops · Topical | 1 Bottle | SAR 20.90 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CASPORYN HC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | CASPER PHARMA LLC | Prescription | 25 May 1975 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | SANDOZ | Prescription | 25 Aug 1983 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | SANDOZ | Prescription | 6 Nov 1985 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · ophthalmic | SANDOZ | Prescription | 11 May 1988 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | BAUSCH AND LOMB INC | Prescription | 29 Dec 1995 |
| OTICAIR | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | BAUSCH AND LOMB INC | Prescription | 28 Aug 1996 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | SCIEGEN PHARMS | Prescription | 1 May 2006 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | AMNEAL | Prescription | 30 Sep 2025 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | AMNEAL | Prescription | 29 Oct 2025 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | ORBICULAR PHARM TECH | Prescription | 27 Aug 2026 |
| CORTISPORIN | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · topical | MONARCH PHARMS | Discontinued | 16 Apr 1963 |
| CORTISPORIN | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · ophthalmic | MONARCH PHARMS | Discontinued | 18 Dec 1964 |
| CORTISPORIN | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution/drops · otic | MONARCH PHARMS | Discontinued | 9 Dec 1975 |
| PEDIOTIC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | MONARCH PHARMS | Discontinued | 29 Sep 1987 |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | SAPTALIS PHARMS | Discontinued | 31 Oct 2005 |
| OTOCORT | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | WATSON LABS | Discontinued | |
| OTOBIONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | SCHERING | Discontinued | |
| NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | solution/drops · otic | PHARMAFAIR | Discontinued | |
| OTICAIR | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | PHARMAFAIR | Discontinued | |
| OTOCORT | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | WATSON LABS | Discontinued | |
| NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · otic | PHARMAFAIR | Discontinued | |
| NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | suspension/drops · ophthalmic | PHARMAFAIR | Discontinued |
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.