Is Dexbrompheniramine + Pseudoephedrine 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 Dexbrompheniramine + Pseudoephedrine.

Is Dexbrompheniramine + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 7 application product lines for Dexbrompheniramine + Pseudoephedrine, including DRIXORAL (Discontinued); DISOPHROL (Discontinued); BROMPHERIL (Discontinued); DISOBROM (Discontinued); DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (Discontinued).

Active substances

Dexbrompheniramine + Pseudoephedrine

SFDA 2
US FDA 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DISOPHROL S-A TAB	6, 120 mg	Tablet · Oral use	8 Blister	SAR 4.90	NCE · Prescription	SCHERING-PLOUGH	Withdrawn by MAH · Not Marketed
DISOPHROL S-A TAB	6, 120 mg	Tablet · Oral use	24 Blister	SAR 14.15	NCE · Prescription	SCHERING-PLOUGH	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
DRIXORAL	6MG;120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	SCHERING PLOUGH	Discontinued	18 Oct 1963
DISOPHROL	6MG;120MG	tablet, extended release · oral	SCHERING PLOUGH	Discontinued	18 Oct 1963
BROMPHERIL	6MG;120MG	tablet, extended release · oral	COPLEY PHARM	Discontinued	22 Jan 1987
DISOBROM	6MG;120MG	tablet, extended release · oral	SANDOZ	Discontinued	30 Sep 1991
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	tablet, extended release · oral	AVANTHI INC	Discontinued	27 Feb 2013
RESPORAL	6MG;120MG	tablet, extended release · oral	PIONEER PHARMS	Discontinued
DISOPHROL	2MG;60MG	tablet · oral	SCHERING	Discontinued

Components

Pseudoephedrine

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.