Is Dextromethorphan + Guaifenesin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Dextromethorphan + Guaifenesin, including CONTRA 15/200 mg softgel capsule (15,200 mg,mg, Capsule, soft, SAR 29.75); GUAPHAN DM (100,10 mg,mg, Syrup, SAR 12.20).

Is Dextromethorphan + Guaifenesin approved by the US FDA?

Drugs@FDA lists 7 application product lines for Dextromethorphan + Guaifenesin, including MUCINEX DM (Over-the-counter); GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (Over-the-counter); GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (Over-the-counter); GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (Over-the-counter); GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (Over-the-counter).

Active substances

Dextromethorphan + Guaifenesin

SFDA 6
US FDA 7
Health Canada 11
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
CONTRA 15/200 mg softgel capsule	15,200 mg,mg	Capsule, soft · Oral use	30 Blister	SAR 29.75	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
GUAPHAN DM	100,10 mg,mg	Syrup · Oral use	1 Bottle	SAR 12.20	Generic · Prescription	RIYADH PHARMA	Valid
CHERACHOL-D SYRUP	2, 20 mg/ml	Oral solution · Oral use	1 Bottle	SAR 9.30	NCE · OTC	PHARMACIA UPJOHN	Withdrawn by MAH · Not Marketed
KAFOSED G SYRUP		Syrup · Oral use	1 Bottle	SAR 5.15	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
ROBITUSSIN-DM SYRUP	3, 20 mg	Syrup · Oral use	1 Bottle	SAR 7.40	Generic · Prescription	FEREVA RICHMOND	Withdrawn by MAH · Not Marketed
VICKS 44 E PEDIATRIC ALCOHOL FREE SYRUP	100,10 mg,mg	Syrup · Oral use	1 Bottle	SAR 5.10	Generic · Prescription	PROCTER & GAMBLE	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION

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

Product	Strength	Form · route	Applicant	Status	First approved
MUCINEX DM	60MG;1.2GM; 30MG;600MG	tablet, extended release · oral	RECKITT BENCKISER	Over-the-counter	29 Apr 2004
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG; 60MG;1.2GM	tablet, extended release · oral	ACTAVIS LABS FL	Over-the-counter	31 Aug 2015
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG; 60MG;1.2GM	tablet, extended release · oral	AUROBINDO PHARMA	Over-the-counter	17 Mar 2017
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM; 30MG;600MG	tablet, extended release · oral	PERRIGO R AND D	Over-the-counter	5 Mar 2018
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG; 60MG;1.2GM	tablet, extended release · oral	AMNEAL PHARMS	Over-the-counter	1 Nov 2018
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG; 60MG;1.2GM	tablet, extended release · oral	SUN PHARM	Over-the-counter	1 Jul 2021
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG; 60MG;1.2GM	tablet, extended release · oral	DR REDDYS	Over-the-counter	1 Aug 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BENYLIN REGULAR STRENGTH COUGH PLUS CHEST CONGESTION RELIEF	01944762	15 MG / 5 ML; 100 MG / 5 ML	SYRUP · ORAL	KENVUE CANADA INC.
COUGH & CHEST CONGESTION	02539195	20 MG / 20 ML; 400 MG / 20 ML	SYRUP · ORAL	LSL MEDPLUS INC
COUGH & CHEST CONGESTION EXTRA STRENGTH	02541890	15 MG / 5 ML; 200 MG / 5 ML	SYRUP · ORAL	CRLS
COUGH & CHEST CONGESTION REGULAR STRENGTH	02541882	100 MG / 5 ML; 15 MG / 5 ML	SYRUP · ORAL	CRLS
JACK & JILL HONEY COUGH & COLD	02522950	50 MG / 5 ML; 5 MG / 5 ML	SYRUP · ORAL	HALEON CANADA ULC
MUCINEX CONGESTION & COUGH	02433257	20 MG / 20 ML; 400 MG / 20 ML	SOLUTION · ORAL	RECKITT BENCKISER (CANADA) INC
MUCUS & PHLEGM RELIEF WITH COUGH CONTROL EXTRA STRENGTH	02540908	200 MG / 5 ML; 15 MG / 5 ML	SYRUP · ORAL	CRLS
ROBITUSSIN COUGH CONTROL	01931024	100 MG / 5 ML; 15 MG / 5 ML	SYRUP · ORAL	HALEON CANADA ULC
ROBITUSSIN EXTRA STRENGTH COUGH CONTROL	02142775	15 MG / 5 ML; 200 MG / 5 ML	SYRUP · ORAL	HALEON CANADA ULC
ROBITUSSIN EXTRA STRENGTH HONEY COUGH & CONGESTION	02485524	400 MG / 20 ML; 20 MG / 20 ML	SYRUP · ORAL	HALEON CANADA ULC
ROBITUSSIN SUGAR FREE COUGH CONTROL	02248568	10 MG / 5 ML; 100 MG / 5 ML	SYRUP · ORAL	GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GUAIFENESIN-DM 100-10 MG/5 ML	$0.02395	per ML	23 Sep 2026
US NADAC	GUAIFENESIN-DM ER 1,200-60 MG	$0.54461	per EA	7 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.