Exidine

NDA 19127, held by Xttrium. Chlorhexidine Gluconate.

As of Nov 13, 2026, NDA 19127 (Exidine), held by Xttrium, was first approved by FDA on Dec 24, 1984, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1984
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses  surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care  healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 24, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Exidine4% · aerosol, metered;topical	Chlorhexidine Gluconate	OTCReference drug

All 14 submissions, including labeling and manufacturing supplements


May 27, 2025	Supplement 27Labeling · Standard review	Approved	Letter
Sep 14, 2017	Supplement 22Labeling · Standard review	Approved	Label Letter
Apr 11, 2013	Supplement 20Labeling · Standard review	Approved	Letter
Jul 11, 2012	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 16, 2009	Supplement 13Manufacturing	Approved	Letter
Jun 30, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 12, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 13, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 19, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 19, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 15, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 28, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 2, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 24, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19127
Drugs@FDA: Overview at FDA
Company: Xttrium

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