Attached herewith is the general classification of cough formulation indicating their respective active ingredients category, prescription requirements and the agency exercising jurisdiction in relation with their regulatory requirement.  All concerned are enjoined to observe and monitor compliance of the regulatory requirements with these pieces of information in view.

Adopted: 23 May 1990

(SGD.) CECILE P. GONZALEZ

Director

 

GENERAL CLASSIFICATION OF COUGH FORMULATION
Active Ingredient	Category	Prescription	Agency with Requirements Jurisdiction
HYDROCODONE OR DIHYDRO-CODEINONE	Prohibited Drugs	Yellow Prescription (DDB Form 1-72)	DDB*
EPHEDRINE & PSEUDO-EPHEDRINE	Regulated Drugs	Yellow Prescription (DDB Form 1-72)	DDB
CODEINE Exempt (BR No. 1, s. 1973)	Preparation	Ordinary Prescription with S-2 license	DDB
EPHEDRINE & PSEUDO-EPHEDRINE IN COMBINATION WITH OTHER INGREDIENTS	Exempt Preparation	Ordinary Prescription with S-2 license	DDB
DEXTROME-TORPHAN (Single Component)	Prescription Drug	Ordinary Prescription	BFAD* *
PHENYLPRO-PANOLAMINE	OTC	NONE	BFAD
MUCOLYTIC AND EXPECTORANT	OTC	NONE	BFAD
ANTIHISTAMINIC	OTC	NONE	BFAD

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^[*] DDB in charge of compliance regulatory requirements covering registration, record-keeping, production, distribution, retail, import and export of dangerous drugs.

^{[* *]} BFAD in charge of registration, licensing, etc. as to efficacy, purity and quality of both dangerous drugs and non-dangerous drugs.