Is Fluorescein registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Fluorescein, including MINIMS FLUORESCEIN SODIUM 2% (2 %, Eye drops, solution, SAR 60.10).

Is Fluorescein approved by the US FDA?

Drugs@FDA lists 8 application product lines for Fluorescein, including FLUORESCITE (Prescription); AK-FLUOR 10% (Prescription); FLUORESCEIN SODIUM (Prescription); FLUORESCEIN SODIUM (Prescription); FLUORESCEIN SODIUM (Prescription).

Is Fluorescein on the WHO Model List of Essential Medicines?

Yes — 14.1. Diagnostic agents > Ophthalmic medicines (core list): Fluorescein.

Are there safety signals or safety updates for Fluorescein?

US FDA: 1 entry (latest 2026-06-10).

Active substance

Fluorescein

SFDA 2
US FDA 8
Health Canada 3
NHS prices 2
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MINIMS FLUORESCEIN SODIUM 2%	2 %	Eye drops, solution · Ophthalmic use	20 Single Dose Container	SAR 60.10	NCE · Prescription	CHAUVIN BAUSCH & LOMB	Valid
FLUORETS OPTH.STRIPS	1 mg	Ophthalmic strip · Ophthalmic use	100 Box	SAR 26.60	NCE · Prescription	CHAUVIN BAUSCH & LOMB	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
FLUORESCITE	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	injectable · intravenous	ALCON LABS INC	Prescription	28 Mar 2006
AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	injectable · intravenous	LONG GROVE PHARMS	Prescription	8 Aug 2008
FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	injectable · intravenous	NEXUS	Prescription	25 Sep 2023
FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	injectable · intravenous	BPI LABS	Prescription	30 Apr 2026
FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML); EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	injectable · intravenous	ZYDUS LIFESCIENCES	Prescription	1 Jun 2026
FUNDUSCEIN-25	25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	NOVARTIS	Discontinued	10 Nov 1976
AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	injectable · intravenous	LONG GROVE PHARMS	Discontinued	8 Aug 2008
FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	injectable · intravenous	NEXUS	Discontinued	25 Sep 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DIOFLUOR STRIPS	02160773	1 MG	STRIP · OPHTHALMIC	DIOPTIC PHARMACEUTICALS INC
FLUORESCITE	00505005	10 % / W/V	SOLUTION · INTRAVENOUS	ALCON CANADA INC
MINIMS FLUORESCEIN SODIUM	02148390	2 % / W/V	DROPS · OPHTHALMIC	BAUSCH & LOMB INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Fluorescein 1% eye drops 0.5ml unit dose preservative free	£10.88	20 unit dose	1 Oct 2026
NHS Drug Tariff	Fluorescein 2% eye drops 0.5ml unit dose preservative free	£11.08	20 unit dose	1 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.

WHO WHO Model List of Essential Medicines (2025)

14.1. Diagnostic agents > Ophthalmic medicines · core
Fluorescein
Local > Ophthalmological > Solution (eye drops): 1% (sodium salt)

Safety signals and safety-related labeling changes

US FDA 10 Jun 2026 FLUORESCITE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for fluorescein →

Combinations containing Fluorescein

Fluorescein + lidocaine

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.