Is Dextromethorphan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Dextromethorphan, including DEXTROKUF 15MG\5ML SYRUP (3 mg/ml, Syrup, SAR 7.20); KAFOSED SYRUP 15MG-5ML (3 mg/ml, Syrup, SAR 10.70); RIAPHAN 15 mg per 5 ml (3 mg/ml, Syrup, SAR 9.60); ROMIN 15 MG-5 ML SYRUP (3 mg/ml, Syrup, SAR 11.50).

Are there safety signals or safety updates for Dextromethorphan?

US FDA: 2 entries (latest 2026-04-30).

Active substance

Dextromethorphan

SFDA 9
Health Canada 10
US price lines 2
NHS prices 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DEXTROKUF 15MG\5ML SYRUP	3 mg/ml	Syrup · Oral use	1 Bag	SAR 7.20	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
KAFOSED SYRUP 15MG-5ML	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 10.70	Generic · Prescription	SPIMACO ADDWAEIH	Valid
RIAPHAN 15 mg per 5 ml	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 9.60	Generic · Prescription	RIYADH PHARMA	Valid
ROMIN 15 MG-5 ML SYRUP	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 11.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CONTRASAL 15MG-5ML SYRUP	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 4.30	NCE · Prescription	Hikma Pharmaceuticals PLC	Withdrawn by MAH · Not Marketed
DEXOFAN 15MG-5ML SYRUP	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 7.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
EXEDEXE 15MG TABLETS	15 mg	Tablet · Oral use	20 Blister	SAR 5.20	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
EXEDEXE 15MG\5ML SYRUP	3 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.35	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
TUSSILAR TAB	15 mg	Tablet · Oral use	20 Blister	SAR 5.20	NCE · OTC	KAHIRA EYGEPT	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BALMINIL DM (3MG/ML SUCROSE FREE)	01928775	15 MG / 5 ML	SYRUP · ORAL	TEVA CANADA LIMITED
BENYLIN EXTRA STRENGTH DRY COUGH	01944738	30 MG / 10 ML	SYRUP · ORAL	KENVUE CANADA INC.
BENYLIN FOR CHILDREN DRY COUGH	02215268	7.5 MG / 5 ML	SOLUTION · ORAL	KENVUE CANADA INC.
BRONCHOPHAN FORTE DM SYR	00522791	15 MG / 5 ML	SYRUP · ORAL	LABORATOIRE ATLAS INC
BUCKLEY'S DRY COUGH EXTRA STRENGTH	02511320	15 MG / 5 ML	SOLUTION · ORAL	HALEON CANADA ULC
DAYQUIL KIDS HONEY	02549360	10 MG / 15 ML	SYRUP · ORAL	PROCTER & GAMBLE INC
DRY COUGH RELIEF EXTRA STRENGTH	02534754	30 MG / 10 ML	SYRUP · ORAL	CRLS
KOFFEX DM	01928783	15 MG / 5 ML	SYRUP · ORAL	TEVA CANADA LIMITED
KOFFEX DM (SUCROSE FREE)	01928791	15 MG / 5 ML	SYRUP · ORAL	TEVA CANADA LIMITED
ROBITUSSIN DM COUGHGELS LIQUI-GELS TOUX	02252554	15 MG	CAPSULE · ORAL	HALEON CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DEXTROMETHORPHAN 15 MG SOFTGEL	$0.1217	per EA	23 Sep 2026
US NADAC	DEXTROMETHORPHAN ER 30 MG/5 ML	$0.06641	per ML	23 Sep 2026
NHS Drug Tariff	Dextromethorphan 7.5mg/5ml oral solution sugar free	£3.56	100 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 30 Apr 2026 AUVELITY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jun 2019 NUEDEXTA — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for dextromethorphan →

Combinations containing Dextromethorphan

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.