Is Fluocinolone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Fluocinolone.

Is Fluocinolone approved by the US FDA?

Drugs@FDA lists 78 application product lines for Fluocinolone, including SYNALAR (Prescription); SYNALAR (Prescription); SYNALAR (Prescription); FLUOCINOLONE ACETONIDE (Prescription); FLUOCINOLONE ACETONIDE (Prescription).

Is Fluocinolone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Fluocinolone.

Are there safety signals or safety updates for Fluocinolone?

US FDA: 4 entries (latest 2025-04-04).

Active substance

Fluocinolone

SFDA 6
US FDA 78
EMA 1
Health Canada 2
US price lines 9
NHS prices 7
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DERMOLAR	0.025 %	Cream · Topical	1 Bottle	SAR 9.30	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
DERMOLAR	0.025 %	Ointment · Topical	1 Bottle	SAR 9.25	NCE · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
PETRALAR 0.025% CREAM	0.025 %	Cream · Topical	1 Tube	SAR 8.35	Generic · Prescription	ARAB CENTER FOR PHARMACEUTICALS & CHEMICAL IND. CO.	Withdrawn by regulatory authority · Not Marketed
PETRALAR-F 0.25% CREAM	0.25 %	Cream · Topical	1 Tube	SAR 13.60	Generic · Prescription	ARAB CENTER FOR PHARMACEUTICALS & CHEMICAL IND. CO.	Withdrawn by regulatory authority · Not Marketed
SYNALAR CREAM	0.025 %	Cream · Topical	1 Tube	SAR 9.65	Generic · Prescription	GRUNENTHAL	Withdrawn by MAH · Not Marketed
SYNALAR OINTMENT	0.025 %	Ointment · Topical	1 Tube	SAR 9.65	Generic · Prescription	GRUNENTHAL	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
SYNALAR	0.025%; 0.01%	cream · topical	EUROFARMA	Prescription	15 Feb 1963
SYNALAR	0.025%	ointment · topical	EUROFARMA	Prescription	19 Jun 1963
SYNALAR	0.01%	solution · topical	EUROFARMA	Prescription	27 May 1964
FLUOCINOLONE ACETONIDE	0.01%	solution · topical	FOUGERA PHARMS INC	Prescription	16 Dec 1982
FLUOCINOLONE ACETONIDE	0.025%	ointment · topical	FOUGERA PHARMS INC	Prescription	16 Dec 1982
FLUOCINOLONE ACETONIDE	0.025%	cream · topical	FOUGERA PHARMS INC	Prescription	16 Dec 1982
FLUOCINOLONE ACETONIDE	0.01%	cream · topical	FOUGERA PHARMS INC	Prescription	16 Dec 1982
FLUOCINOLONE ACETONIDE	0.01%	solution · topical	SUN PHARMA CANADA	Prescription	11 Sep 1985
DERMA-SMOOTHE/FS	0.01%	oil · topical	HILL DERMAC	Prescription	3 Feb 1988
DERMOTIC	0.01%	oil/drops · otic	HILL DERMAC	Prescription	3 Feb 1988
FLUOCINOLONE ACETONIDE	0.025%	ointment · topical	COSETTE PHARMS NC	Prescription	26 Jul 1988
FLUOCINOLONE ACETONIDE	0.01%	cream · topical	COSETTE PHARMS NC	Prescription	26 Jul 1988
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	PADAGIS ISRAEL	Prescription	9 Aug 2013
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	PADAGIS ISRAEL	Prescription	9 Aug 2013
ILUVIEN	0.19MG	implant · intravitreal	ALIMERA SCIENCES INC	Prescription	26 Sep 2014
FLUOCINOLONE ACETONIDE	0.01%	solution · topical	LUPIN	Prescription	2 Sep 2015
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	RISING	Prescription	25 Apr 2016
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	RISING	Prescription	25 Apr 2016
FLUOCINOLONE ACETONIDE	0.01%	oil/drops · otic	RISING	Prescription	25 Apr 2016
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	SUN PHARMA CANADA	Prescription	19 May 2016
FLUOCINOLONE ACETONIDE	0.01%	oil · topical	SUN PHARMA CANADA	Prescription	19 May 2016
FLUOCINOLONE ACETONIDE	0.01%	oil/drops · otic	PADAGIS ISRAEL	Prescription	17 Jul 2017
FLUOCINOLONE ACETONIDE	0.01%	solution · topical	CHARTWELL RX	Prescription	26 Dec 2017
FLAC	0.01%	oil/drops · otic	ANDA REPOSITORY	Prescription	11 Apr 2018
YUTIQ	0.18MG	implant · intravitreal	ALIMERA SCIENCES INC	Prescription	12 Oct 2018

53 more — full table

EMA European Union — centrally authorised medicines

Retisert Bausch Lomb Ireland · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DERMA SMOOTHE/FS LIQ 0.01%	00873292	0.01 %	EMULSION · TOPICAL	HILL DERMACEUTICALS INC
DERMOTIC OIL EAR DROPS	02300559	0.01 % / W/V	SOLUTION · OTIC	HILL DERMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FLUOCINOLONE 0.01% BODY OIL	$0.17545	per ML	23 Sep 2026
US NADAC	FLUOCINOLONE 0.01% CREAM	$1.70556	per GM	23 Sep 2026
US NADAC	FLUOCINOLONE 0.01% CREAM	$1.19699	per GM	23 Sep 2026
US NADAC	FLUOCINOLONE 0.01% SCALP OIL	$0.17118	per ML	23 Sep 2026
US NADAC	FLUOCINOLONE 0.01% SOLUTION	$0.20036	per ML	23 Sep 2026
US NADAC	FLUOCINOLONE 0.025% CREAM	$1.39123	per GM	23 Sep 2026
US NADAC	FLUOCINOLONE 0.025% CREAM	$1.01007	per GM	23 Sep 2026
US NADAC	FLUOCINOLONE 0.025% OINTMENT	$1.25943	per GM	23 Sep 2026
US NADAC	FLUOCINOLONE 0.025% OINTMENT	$0.57096	per GM	23 Sep 2026
NHS Drug Tariff	Fluocinolone acetonide 0.00625% ointment	£4.84	50 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% cream	£4.14	30 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% cream	£11.75	100 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% gel	£5.56	30 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% gel	£10.02	60 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% ointment	£4.14	30 gram	1 Oct 2026
NHS Drug Tariff	Fluocinolone acetonide 0.025% ointment	£11.75	100 gram	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.

Safety signals and safety-related labeling changes

US FDA 4 Apr 2025 RETISERT — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 12 Mar 2025 ILUVIEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 30 Aug 2024 DERMA-SMOOTHE/FS — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 30 Aug 2024 DERMOTIC — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for fluocinolone →

Combinations containing Fluocinolone

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.