Is Ibuprofen + Pseudoephedrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ibuprofen + Pseudoephedrine, including ADVIL COLD AND SINUS CAPLET (200,30 mg,mg, Tablet, SAR 11.75); SAPOFEN COLD & FLU TABLET (200,30 mg,mg, Film-coated tablet, SAR 9.00).

Is Ibuprofen + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 11 application product lines for Ibuprofen + Pseudoephedrine, including ADVIL COLD AND SINUS (Over-the-counter); SINE-AID IB (Over-the-counter); CHILDREN'S MOTRIN COLD (Over-the-counter); CHILDREN'S ADVIL COLD (Over-the-counter); ADVIL COLD AND SINUS (Over-the-counter).

Active substances

Ibuprofen + Pseudoephedrine

SFDA 4
US FDA 11
Health Canada 5
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADVIL COLD AND SINUS CAPLET	200,30 mg,mg	Tablet · Oral use	20 Blister	SAR 11.75	Generic · OTC	GLAXOSMITHKLINE (GSK)	Valid
ADVIL COLD AND SINUS CAPLET	200,30 mg,mg	Tablet · Oral use	10 Blister	SAR 6.70	NCE · OTC	PFIZER	Valid
SAPOFEN COLD & FLU TABLET	200,30 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 9.00	Generic · OTC	SPIMACO ADDWAEIH	Valid
SAPOFEN COLD & FLU SUSPENSION	20, 3 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 11.60	Generic · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed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
ADVIL COLD AND SINUS	200MG;30MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	19 Sep 1989
SINE-AID IB	200MG;30MG	tablet · oral	KENVUE BRANDS	Over-the-counter	31 Dec 1992
CHILDREN'S MOTRIN COLD	100MG/5ML;15MG/5ML	suspension · oral	KENVUE BRANDS	Over-the-counter	1 Aug 2000
CHILDREN'S ADVIL COLD	100MG/5ML;15MG/5ML	suspension · oral	HALEON US HOLDINGS	Over-the-counter	18 Apr 2002
ADVIL COLD AND SINUS	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	capsule · oral	HALEON US HOLDINGS	Over-the-counter	30 May 2002
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	tablet · oral	STRIDES PHARMA	Over-the-counter	14 Aug 2006
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	capsule · oral	AUROBINDO PHARMA	Over-the-counter	1 Dec 2017
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	tablet · oral	AUROBINDO PHARMA LTD	Over-the-counter	10 Mar 2023
IBUPROHM COLD AND SINUS	200MG;30MG	tablet · oral	OHM LABS	Discontinued	17 Apr 2001
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	tablet · oral	CONTRACT PHARMACAL	Discontinued	8 Apr 2002
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	suspension · oral	PERRIGO	Discontinued	5 Nov 2003

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVIL COLD & SINUS LIQUI-GELS	02250705	30 MG; 200 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL COLD AND SINUS	02036312	30 MG; 200 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL COLD AND SINUS DAYTIME	02267616	200 MG; 30 MG	TABLET · ORAL	HALEON CANADA ULC
COLD + SINUS	02352281	200 MG; 30 MG	TABLET · ORAL	VITA HEALTH PRODUCTS INC
SUDAFED SINUS ADVANCE	02242217	30 MG; 200 MG	TABLET · ORAL	KENVUE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Ibuprofen 200mg / Pseudoephedrine hydrochloride 30mg tablets	£3.39	12 tablet	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg / Pseudoephedrine hydrochloride 30mg tablets	£5.21	24 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

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.