Regulatory PathRegulatory requirements compared

Active substances

Diphenhydramine + Paracetamol + Pseudoephedrine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FLUTAB TABLET500,30,25 mg,mg,mgTablet · Oral use30 BlisterSAR 14.85Generic · OTCSPIMACO ADDWAEIHValid
OTRICOLD FILM COATED TABLETS500, 30, 25 mgTablet · Oral use20 BlisterSAR 8.05Generic · OTCNOVARTISWithdrawn by MAH · Not Marketed

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BENADRYL ALLERGY, SINUS & PAIN TOTAL0225099325 MG; 30 MG; 500 MGTABLET · ORALKENVUE CANADA INC.
BENYLIN EXTRA STRENGTH ALL-IN-ONE COLD, FLU & COUGH NIGHT02256576500 MG; 30 MG; 25 MGTABLET · ORALKENVUE CANADA INC.
EXTRA STRENGTH ALLERGY TOTAL0230383330 MG; 25 MG; 500 MGTABLET · ORALVITA HEALTH PRODUCTS INC
EXTRA STRENGTH FLU RELIEF NIGHTIME0224870025 MG; 30 MG; 500 MGTABLET · ORALVITA HEALTH PRODUCTS INC
EXTRA STRENGTH SINUTAB SINUS NIGHTTIME0221524130 MG; 25 MG; 500 MGTABLET · ORALKENVUE CANADA INC.
EXTRA STRENGTH TYLENOL COMPLETE COLD, COUGH & FLU NIGHTTIME0236576625 MG; 500 MG; 30 MGTABLET · ORALKENVUE CANADA INC.
NIGHTTIME FLU, COUGH & COLD COMPLETE RELIEF EXTRA STRENGTH0240497430 MG; 500 MG; 25 MGTABLET · ORALVITA HEALTH PRODUCTS INC
NIGHTTIME TOTAL COLD AND FLU02305305500 MG; 25 MG; 30 MGTABLET · ORALVITA HEALTH PRODUCTS INC

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.