Is Guaifenesin 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 Guaifenesin, including GUAPHAN (20 mg/ml, Syrup, SAR 6.50); MUCINEX 600MG EXTENDED RELEASE BI-LAYER TABLET (600 mg, Extended-release tablet, SAR 28.85); PECTAL 100MG\5ML SYRUP (20 mg/ml, Syrup, SAR 7.80).

Is Guaifenesin approved by the US FDA?

Drugs@FDA lists 10 application product lines for Guaifenesin, including MUCINEX (Over-the-counter); GUAIFENESIN (Over-the-counter); GUAIFENESIN (Over-the-counter); GUAIFENESIN (Over-the-counter); GUAIFENESIN (Over-the-counter).

Are there safety signals or safety updates for Guaifenesin?

US FDA: 5 entries (latest 2025-12-22).

Active substance

Guaifenesin

SFDA 4
US FDA 10
Health Canada 5
US price lines 5
NHS prices 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GUAPHAN	20 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.50	Generic · OTC	RIYADH PHARMA	Valid
MUCINEX 600MG EXTENDED RELEASE BI-LAYER TABLET	600 mg	Extended-release tablet · Oral use	20 Blister	SAR 28.85	Generic · Prescription	RECKITT BENCKISER I.N.C	Valid
PECTAL 100MG\5ML SYRUP	20 mg/ml	Syrup · Oral use	1 Bottle	SAR 7.80	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
ROBITUSSIN SYRUP	24 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.70	NCE · OTC	FEREVA RICHMOND	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
MUCINEX	600MG; 1.2GM	tablet, extended release · oral	RECKITT BENCKISER	Over-the-counter	12 Jul 2002
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	PERRIGO R AND D	Over-the-counter	23 Nov 2011
GUAIFENESIN	1.2GM	tablet, extended release · oral	ACTAVIS LABS FL	Over-the-counter	3 Sep 2015
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	GUARDIAN DRUG	Over-the-counter	6 Sep 2017
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	AMNEAL PHARMS	Over-the-counter	11 Jul 2018
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	OHM LABS INC	Over-the-counter	16 Jul 2018
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	AUROBINDO PHARMA	Over-the-counter	21 Oct 2019
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	GRANULES	Over-the-counter	8 May 2020
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	DR REDDYS	Over-the-counter	15 Mar 2022
GUAIFENESIN	600MG; 1.2GM	tablet, extended release · oral	PHARMAZONE	Over-the-counter	21 Aug 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BALMINIL EXPECTORANT (SUCROSE FREE)	00609951	100 MG / 5 ML	SYRUP · ORAL	TEVA CANADA LIMITED
BRONCHOPHAN EXPECTORANT (SANS SUCROSE)	02121999	100 MG / 5 ML	SYRUP · ORAL	LABORATOIRE ATLAS INC
MUCINEX CHEST CONGESTION	02434725	600 MG	TABLET (IMMEDIATE- AND EXTENDED-RELEASE) · ORAL	RECKITT BENCKISER (CANADA) INC
MUCUS & PHLEGM RELIEF EXTRA STRENGTH	02534762	200 MG / 5 ML	SYRUP · ORAL	CRLS
ROBITUSSIN EXTRA STRENGTH MUCUS AND PHLEGM	02142783	200 MG / 5 ML	SYRUP · ORAL	HALEON CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GUAIFENESIN 100 MG/5 ML SOLN	$0.01103	per ML	23 Sep 2026
US NADAC	GUAIFENESIN 200 MG TABLET	$0.03234	per EA	23 Sep 2026
US NADAC	GUAIFENESIN 400 MG TABLET	$0.06559	per EA	23 Sep 2026
US NADAC	GUAIFENESIN ER 1,200 MG TABLET	$0.43164	per EA	23 Sep 2026
US NADAC	GUAIFENESIN ER 600 MG TABLET	$0.28398	per EA	23 Sep 2026
NHS Drug Tariff	Guaifenesin 100mg/5ml oral solution sugar free	£3.56	100 ml	1 Oct 2026
NHS Drug Tariff	Guaifenesin 66.67mg/5ml oral solution sugar free	£4.10	150 ml	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.

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 FLOWTUSS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 HYCOFENIX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 OBREDON — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 XTRELUS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 31 Oct 2018 HYDROCODONE BITARTRATE AND GUAIFENESIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for guaifenesin →

Combinations containing Guaifenesin

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.