FDA — authorised 14 January 1975
- Application: ANDA084149
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: BENOXINATE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 BENOXINATE HYDROCHLORIDE in United States
FDA authorised BENOXINATE HYDROCHLORIDE on 14 January 1975 · 60 US adverse-event reports
Marketing authorisations
FDA — authorised 14 December 2017
- Application: NDA208582
- Marketing authorisation holder: ALTAIRE PHARMS INC
- Local brand name: ALTAFLUOR BENOX
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 March 2020
- Application: NDA211039
- Marketing authorisation holder: BAUSCH LOMB IRELAND
- Local brand name: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 60
Most-reported reactions
- Corneal Disorder — 10 reports (16.67%)
- Dyspnoea — 8 reports (13.33%)
- Headache — 7 reports (11.67%)
- Fatigue — 6 reports (10%)
- Candida Endophthalmitis — 5 reports (8.33%)
- Endophthalmitis — 5 reports (8.33%)
- Erythema — 5 reports (8.33%)
- Urticaria — 5 reports (8.33%)
- Vision Blurred — 5 reports (8.33%)
- Anaphylactic Reaction — 4 reports (6.67%)
BENOXINATE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BENOXINATE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 14 January 1975; FDA authorised it on 14 December 2017; FDA authorised it on 9 March 2020.
Who is the marketing authorisation holder for BENOXINATE HYDROCHLORIDE in United States?
SOLA BARNES HIND holds the US marketing authorisation.