Is Betamethasone + Calcipotriol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Betamethasone + Calcipotriol, including DAIVOBET GEL (500,50 µg,µg, Gel, SAR 189.60); DAIVOBET OINTMENT (500,50 µg,µg, Ointment, SAR 148.35); Enstilar (500,50 µg,µg, Cutaneous foam, SAR 170.70); ROLIP ointment (500,50 µg,µg, Ointment, SAR 70.45).

Is Betamethasone + Calcipotriol approved by the US FDA?

Drugs@FDA lists 10 application product lines for Betamethasone + Calcipotriol, including TACLONEX (Prescription); TACLONEX (Prescription); CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (Prescription); ENSTILAR (Prescription); CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (Prescription).

Active substances

Betamethasone + Calcipotriol

SFDA 6
US FDA 10
Health Canada 6
US price lines 6
NHS prices 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DAIVOBET GEL	500,50 µg,µg	Gel · Topical	1 Tube	SAR 189.60	NCE · Prescription	Leo Pharma	Valid
DAIVOBET OINTMENT	500,50 µg,µg	Ointment · Topical	1 Tube	SAR 148.35	NCE · Prescription	Leo Pharma	Valid
Enstilar	500,50 µg,µg	Cutaneous foam · Cutaneous use	1 Pressurised container	SAR 170.70	NCE · Prescription	Leo Pharma	Valid
ROLIP ointment	500,50 µg,µg	Ointment · Topical	1 Tube	SAR 70.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
DAIVOBET GEL	500,50 µg,µg	Gel · Topical	1 Tube	SAR 74.15	NCE · Prescription	Leo Pharma	Withdrawn by MAH · Not Marketed
DAIVOBET OINTMENT	500,50 µg,µg	Ointment · Topical	1 Tube	SAR 74.15	NCE · Prescription	Leo Pharma	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

GRAFT VERSUS HOST DISEASE; PSORIASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TACLONEX	0.064%;0.005%	ointment · topical	LEO PHARMA AS	Prescription	9 Jan 2006
TACLONEX	0.064%;0.005%	suspension · topical	LEO PHARMA AS	Prescription	9 May 2008
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	0.064%;0.005%	ointment · topical	PADAGIS ISRAEL	Prescription	12 Dec 2014
ENSTILAR	0.064%;0.005%	aerosol, foam · topical	LEO PHARMA AS	Prescription	16 Oct 2015
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	0.064%;0.005%	suspension · topical	COSETTE PHARMS NC	Prescription	11 May 2020
WYNZORA	0.064%;0.005%	cream · topical	MC2	Prescription	20 Jul 2020
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	0.064%;0.005%	suspension · topical	SUN PHARMA CANADA	Prescription	2 Sep 2020
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	0.064%;0.005%	ointment · topical	CHARTWELL RX	Discontinued	14 Jan 2013
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE	0.064%;0.005%	suspension · topical	PADAGIS ISRAEL	Discontinued	11 Sep 2020
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	0.064%;0.005%	aerosol, foam · topical	GLENMARK PHARMS LTD	Discontinued	21 Mar 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DOVOBET GEL	02319012	50 MCG / G; 0.5 MG / G	GEL · TOPICAL	LEO PHARMA INC
DOVOBET OINTMENT	02244126	50 MCG / G; 0.5 MG / G	OINTMENT · TOPICAL	LEO PHARMA INC
ENSTILAR	02457393	50 MCG / G; 0.5 MG / G	AEROSOL (FOAM) · TOPICAL	LEO PHARMA INC
TARO-CALCIPOTRIOL / BETAMETHASONE GEL	02525178	0.5 MG / G; 50 MCG / G	GEL · TOPICAL	TARO PHARMACEUTICALS INC
TEVA-BETAMETHASONE/ CALCIPOTRIOL	02427419	0.5 MG / G; 50 MCG / G	OINTMENT · TOPICAL	TEVA CANADA LIMITED
WYNZORA	02563010	0.5 MG / G; 0.05 MG / G	CREAM · TOPICAL	KNIGHT THERAPEUTICS INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% OINTMENT	$1.43306	per GM	23 Sep 2026
US NADAC	CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% OINTMENT	$2.1825	per GM	23 Sep 2026
US NADAC	CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% SUSPENSION	$1.42087	per GM	23 Sep 2026
US NADAC	CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% SUSPENSION	$1.21327	per GM	19 Aug 2026
US NADAC	ENSTILAR 0.005%-0.064% FOAM	$21.8397	per GM	23 Sep 2026
US NADAC	TACLONEX 0.005%-0.064% SUSPENSION	$20.69675	per GM	19 Nov 2025
NHS Drug Tariff	Calcipotriol 0.005% / Betamethasone dipropionate 0.05% cream	£35.66	60 gram	1 Oct 2026
NHS Drug Tariff	Calcipotriol 0.005% / Betamethasone dipropionate 0.05% gel	£37.21	60 gram	1 Oct 2026
NHS Drug Tariff	Calcipotriol 0.005% / Betamethasone dipropionate 0.05% ointment	£19.84	30 gram	1 Oct 2026
NHS Drug Tariff	Calcipotriol 50micrograms/g / Betamethasone dipropionate 500micrograms/g foam	£39.68	60 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.

Components

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.