Dyna-Hex 2

NDA 19422, held by Xttrium. Chlorhexidine Gluconate.

As of Nov 14, 2026, NDA 19422 (Dyna-Hex 2), held by Xttrium, was first approved by FDA on Dec 17, 1985, with 34 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1985
Review: Standard
Supplements approved: 34
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 35 submissions below


Dec 19, 2003	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 27, 1989	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 17, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dyna-Hex 22% · solution;topical	Chlorhexidine Gluconate	OTCReference drug

All 35 submissions, including labeling and manufacturing supplements


Jul 25, 2026	Supplement 56Labeling · Standard review	Approved	Letter Label
Feb 3, 2026	Supplement 55Labeling · Standard review	Approved	Label Letter
Jan 25, 2019	Supplement 49Manufacturing · Standard review	Approved	Letter Label
Sep 15, 2017	Supplement 47Labeling · Standard review	Approved	Letter
Apr 11, 2016	Supplement 46Manufacturing · Standard review	Approved	None posted
Mar 24, 2016	Supplement 45Manufacturing · Standard review	Approved	None posted
Dec 12, 2012	Supplement 43Labeling · Standard review	Approved	Label Letter
Feb 25, 2009	Supplement 37Manufacturing	Approved	Letter
Feb 25, 2009	Supplement 36Manufacturing	Approved	Letter
Dec 20, 2004	Supplement 33Manufacturing · Standard review	Approved	Letter
Dec 19, 2003	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Review Letter
Mar 29, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 29Manufacturing · Standard review	Approved	None posted
Oct 19, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 30, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 8, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 17, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 11, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
May 6, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 3, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 12, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 6, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 6, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
May 10, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
May 10, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 6, 1992	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 27, 1989	Supplement 1Efficacy (new indication or use)	Approved	None posted
Jul 28, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 12, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 28, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 2, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 16, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 16, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 17, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19422
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