Is Chlorphenamine + Pseudoephedrine 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 Chlorphenamine + Pseudoephedrine, including ALLERGETIN SYRUP (2,30 mg,mg, Syrup, SAR 2.55).

Is Chlorphenamine + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 7 application product lines for Chlorphenamine + Pseudoephedrine, including CHLOR-TRIMETON (Discontinued); PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (Discontinued); PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (Discontinued); ISOCLOR (Discontinued); PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (Discontinued).

Active substances

Chlorphenamine + 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
ALLERGETIN SYRUP	2,30 mg,mg	Syrup · Oral use	1 Bottle	SAR 2.55	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
FLUMED	0.4, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 2.75	NCE · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE COUGH; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION

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

Product	Strength	Form · route	Applicant	Status	First approved
CHLOR-TRIMETON	8MG;120MG	tablet, extended release · oral	BAYER HEALTHCARE LLC	Discontinued	31 Mar 1981
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	12MG;120MG	capsule, extended release · oral	GRAHAM DM	Discontinued	18 Mar 1985
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	8MG;120MG	capsule, extended release · oral	GRAHAM DM	Discontinued	20 Mar 1985
ISOCLOR	8MG;120MG	capsule, extended release · oral	FISONS	Discontinued	6 Mar 1986
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	8MG;120MG	capsule, extended release · oral	CENT PHARMS	Discontinued	2 Aug 1988
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	12MG;120MG	capsule, extended release · oral	KV PHARM	Discontinued
CODIMAL-L.A. 12	12MG;120MG	capsule, extended release · oral	SCHWARZ PHARMA	Discontinued

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.