Is Guaifenesin + 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 Guaifenesin + Pseudoephedrine.

Is Guaifenesin + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 7 application product lines for Guaifenesin + Pseudoephedrine, including MUCINEX D (Over-the-counter); GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter).

Active substances

Guaifenesin + Pseudoephedrine

SFDA 2
US FDA 7
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GUAFEDRIN	10, 6 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.15	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ROBITUSSIN-PE SYRUP	20,6 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 6.70	NCE · OTC	FEREVA RICHMOND	Withdrawn by regulatory authority · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
MUCINEX D	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	RECKITT BENCKISER	Over-the-counter	22 Jun 2004
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	ACTAVIS LABS FL	Over-the-counter	27 May 2015
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	DR REDDYS	Over-the-counter	29 Dec 2017
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	AUROBINDO PHARMA LTD	Over-the-counter	25 Mar 2020
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	SUN PHARM INDS INC	Over-the-counter	28 Apr 2020
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	L PERRIGO CO	Over-the-counter	1 Feb 2022
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG; 1.2GM;120MG	tablet, extended release · oral	GRANULES	Discontinued	22 Aug 2022

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GUAIFENESIN-PSE ER 1200-120 MG	$0.42347	per EA	23 Sep 2026
US NADAC	GUAIFENESIN-PSE ER 600-60 MG	$0.38412	per EA	23 Sep 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.