Is Pseudoephedrine + Triprolidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Pseudoephedrine + Triprolidine, including RINOFED (6,0.25 mg/ml,mg/ml, Syrup, SAR 3.85); Rinofed Cold & Allergy Tablets (60,2.5 mg,mg, Tablet, SAR 8.00); SEDOFAN (60,2.5 mg,mg, Tablet, SAR 8.00); SEDOFAN SYRUP. (6,0.25 mg/ml,mg/ml, Syrup, SAR 3.85); TRIPOFED SYRUP (6,0.25 mg/ml,mg/ml, Syrup, SAR 2.95).

Is Pseudoephedrine + Triprolidine approved by the US FDA?

Drugs@FDA lists 16 application product lines for Pseudoephedrine + Triprolidine, including ACTAHIST (Discontinued); HISTAFED (Discontinued); TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (Discontinued); ALLERFED (Discontinued); TRILITRON (Discontinued).

Active substances

Pseudoephedrine + Triprolidine

SFDA 18
US FDA 16
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RINOFED	6,0.25 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 3.85	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
Rinofed Cold & Allergy Tablets	60,2.5 mg,mg	Tablet · Oral use	30 Blister	SAR 8.00	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
SEDOFAN	60,2.5 mg,mg	Tablet · Oral use	30 Blister	SAR 8.00	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
SEDOFAN SYRUP.	6,0.25 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 3.85	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
TRIPOFED SYRUP	6,0.25 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 2.95	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
UNIFED SYRUP	6,0.25 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 2.95	Generic · OTC	UNITED PHARMACEUTICAL CO.	Valid
ACTIFED SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.25	Generic · OTC	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
ACTIFED TAB	2.5, 60 mg	Tablet · Oral use	24 Blister	SAR 7.75	Generic · OTC	GLAXO SAUDI ARABIA	Withdrawn by MAH · Not Marketed
ACTIFED TAB	2.5 , 60 mg	Tablet · Oral use	25 Blister	SAR 8.10	Generic · OTC	GLAXO SAUDI ARABIA	Withdrawn by MAH · Not Marketed
COLDACT SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.10	Generic · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
COLFED 120ML	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.30	Generic · OTC	APM	Withdrawn by MAH · Not Marketed
FLU_CARE	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.45	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
HISTAFED SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 4.25	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
HISTAFED TAB.	2.5 , 60 mg	Tablet · Oral use	30 Blister	SAR 8.85	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
HISTARHINE SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Ampoule	SAR 3.65	Generic · OTC	ALAMRIAH FOR PHARMACEUTICALS INDUSTRIES	Withdrawn by MAH · Not Marketed
NEOCOLD SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 2.65	Generic · OTC	NEOPHARMA	Suspended · Not Marketed
TRIFED SYRUP	0.25, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 4.05	NCE · OTC	Hikma Pharmaceuticals PLC	Withdrawn by MAH · Not Marketed
TRIFED TAB	2.5, 60 mg	Tablet · Oral use	20 Blister	SAR 4.70	NCE · OTC	Hikma Pharmaceuticals PLC	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
ACTAHIST	30MG/5ML;1.25MG/5ML	syrup · oral	CENCI	Discontinued	9 Feb 1984
HISTAFED	30MG/5ML;1.25MG/5ML	syrup · oral	CENCI	Discontinued	20 Apr 1984
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;2.5MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	12 Dec 1984
ALLERFED	60MG;2.5MG	tablet · oral	PVT FORM	Discontinued	31 Jan 1985
TRILITRON	30MG/5ML;1.25MG/5ML	syrup · oral	NEWTRON PHARMS	Discontinued	12 Feb 1985
CORPHED	60MG;2.5MG	tablet · oral	CHARTWELL RX	Discontinued	11 Apr 1985
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE	60MG;2.5MG	tablet · oral	SANDOZ	Discontinued	16 Sep 1994
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	120MG;5MG	capsule, extended release · oral	KV PHARM	Discontinued
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	120MG;5MG	tablet, extended release · oral	KV PHARM	Discontinued
MYFED	30MG/5ML;1.25MG/5ML	syrup · oral	USL PHARMA	Discontinued
TRIPROLIDINE AND PSEUDOEPHEDRINE	60MG;2.5MG	tablet · oral	WEST WARD	Discontinued
TRIPROLIDINE AND PSEUDOEPHEDRINE	60MG;2.5MG	tablet · oral	WATSON LABS	Discontinued
TRILITRON	60MG;2.5MG	tablet · oral	NEWTRON PHARMS	Discontinued
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;2.5MG	tablet · oral	SUPERPHARM	Discontinued
TRIPHED	60MG;2.5MG	tablet · oral	TEVA	Discontinued
ACTIFED	120MG;5MG	capsule, extended release · oral	GLAXOSMITHKLINE	Discontinued

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Pseudoephedrine hydrochloride 60mg / Triprolidine 2.5mg tablets	£4.41	12 tablet	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

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.