Benadryl

NDA 6146, held by Mcneil Cons. Diphenhydramine Hydrochloride.

As of Nov 13, 2026, NDA 6146 (Benadryl), held by Mcneil Cons, was first approved by FDA on Mar 6, 1947, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 6, 1947
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 6, 1947	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Benadryl10MG/ML · injectable;injection	Diphenhydramine Hydrochloride	Discontinued
Benadryl50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Diphenhydramine Hydrochloride	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Jul 1, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 29, 1993	Supplement 12Labeling · Standard review	Approved	None posted
Aug 20, 1992	Supplement 11Labeling · Standard review	Approved	None posted
Jun 24, 1986	Supplement 9Labeling · Standard review	Approved	None posted
Jun 24, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 10, 1984	Supplement 6Labeling · Standard review	Approved	None posted
Mar 6, 1947	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 6146
Drugs@FDA: Overview at FDA
Company: Mcneil Cons

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters