Prescription medicine
Benoxinate and fluorescein Brand names: Altafluor; first approved as Altafluor Benox
Benoxinate and fluorescein (Altafluor Benox) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the benoxinate and fluorescein FDA label on DailyMed (effective May 12, 2025, Bausch & Lomb Incorporated); the NDA 208582 record on Drugs@FDA; every benoxinate and fluorescein label on DailyMed.
Highlights of the record
FDA label of May 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.
Forms and strengths
- 2.5 mg/ml / 4 mg/ml
- 2.6 mg/ml / 4.4 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- December 14, 2017 Altafluor Benox, Altaire Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 15, 2037 Fluorescein Sodium And Benoxinate Hydrochloride solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9 through July 30, 2026
What is benoxinate and fluorescein used for?
From the label: indications and usageFluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic.
FDA pharmacologic class: Diagnostic Dye.
Source: FDA drug label (Fluorescein Sodium and Benoxinate Hydrochloride), Bausch & Lomb Incorporated, effective May 12, 2025 (SPL set 1797c5ef-66c4-4cf8-b62d-b484242be2ee), via openFDA; the full label on DailyMed
Is there a generic for benoxinate and fluorescein (Altafluor Benox)?
No generic benoxinate and fluorescein is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Altafluor Benox solution/drops; a patent listed only for Fluorescein Sodium And Benoxinate Hydrochloride solution/drops runs to November 15, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for benoxinate and fluorescein?
The FDA Adverse Event Reporting System holds 9 reports that list benoxinate and fluorescein among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other diagnostic dyes
- the pharmacologic class, with prices and generics
- Benoxinate and fluorescein side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other