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Warner-Lambert's diphenhydramine

Executive Summary

Petition to add diphenhydramine to the OTC final monograph for antitussives submitted to FDA. The ingredient is a Category I antihistamine, but was not included in the antitussive monograph because Warner-Lambert's NDA data on antitussive use was considered confidential. Diphenhydramine is the active ingredient in Warner-Lambert's antitussive cough syrup Benylin, which has been marketed OTC since 1981. Adding the ingredient to the antitussive monograph may allow Warner-Lambert to expand its Benylin line to include combination products without having to submit supplemental NDAs.

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