Regulatory PathRegulatory requirements compared

Active substances

Diphenhydramine + Sodium citrate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMYDRAMINE EXPECTORANT SYRUP SUGAR FREE5.7,1.4 mg/ml,mg/mlSyrup · Oral use1 BottleSAR 5.15NCE · OTCGulf Pharmaceutical Industries (Julphar)Valid
AMYDRAMINE PAEDIATRIC SYRUP5.7,1.4 mg/ml,mg/mlSyrup · Oral use1 BottleSAR 5.15Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
Indications — CHI Daman Drug Formulary

ACUTE COUGH; ALLERGIC CONJUCTIVITIS (AC); BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; RENAL TRANSPLANT; SCHIZOPHRENIA

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.