Medicine
Benoxinate and Fluorescein 4.4 mg/2.6 mg per mL eye drops
Benoxinate and Fluorescein 4.4 mg/2.6 mg per mL eye drops is a generic prescription medicine for ophthalmic use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light…
Key facts
- Active ingredient (INN)
- Benoxinate and Fluorescein
- Brand
- Sold under the generic name
- Strength
- 4.4 mg/2.6 mg per mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Manufacturers
- Bausch & LombBausch & Lomb Americas
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. After opening, can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 March 2020
- Identifiers
- RxCUI 2287005DailyMed set ID f935b5f8-dc6e-4425-a668-968ee3855f51, 1797c5ef-66c4-4cf8-b62d-b484242be2eeNDC 82260-734, 24208-734Application NDA211039
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 5 mL in 1 bottle, glass | 24208-734-05 | Bausch & Lomb | 20 March 2020 |
| 1 bottle, glass in 1 carton / 5 mL in 1 bottle, glass | 82260-734-05 | Bausch & Lomb Americas | 20 March 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 December 2017 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Benoxinate and Fluorescein
Clinical summary
Benoxinate and Fluorescein is a fixed-dose combination medicine indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. It is available as eye drops and ophthalmic solution. MedsAcross supplies Benoxinate and Fluorescein for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Benoxinate and FluoresceinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ALTAFLUOR prescribing information (Altaire Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Benoxinate and Fluorescein 4.4 mg/2.6 mg per mL eye drops for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.