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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 019014

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NDA 019014 describes BENYLIN, which is a drug marketed by Parke Davis and is included in two NDAs. Additional details are available on the BENYLIN profile page.

The generic ingredient in BENYLIN is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

Summary for 019014

Tradename:	BENYLIN
Applicant:	Parke Davis
Ingredient:	diphenhydramine hydrochloride; pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	12.5MG/5ML;30MG/5ML
Approval Date:	Jun 11, 1985	TE:		RLD:	No

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