Cida-Stat, Chg Scrub

NDA 19258, held by Ecolab. Chlorhexidine Gluconate.

As of Nov 13, 2026, NDA 19258 (Cida-Stat, Chg Scrub), held by Ecolab, was first approved by FDA on Jul 22, 1986, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 22, 1986
Review: Standard
Supplements approved: 17
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 skin wound and general skin cleansing

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 22, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cida-Stat2% · solution;topical	Chlorhexidine Gluconate	OTC
Chg Scrub4% · solution;topical	Chlorhexidine Gluconate	OTC

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 10, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 14, 2016	Supplement 23Manufacturing · Standard review	Approved	Letter Label
Dec 28, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 5, 2015	Supplement 21Manufacturing · Standard review	Approved	Letter
Dec 16, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
May 17, 2012	Supplement 19Labeling · Standard review	Approved	Letter
Apr 23, 2010	Supplement 16Labeling · Standard review	Approved	Letter
Apr 3, 2006	Supplement 14Manufacturing · Standard review	Approved	Letter
Feb 15, 2005	Supplement 11Manufacturing · Standard review	Approved	Letter
Dec 20, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 25, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 8, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Aug 16, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
May 10, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
May 6, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 2, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 22, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19258
Drugs@FDA: Overview at FDA
Company: Ecolab

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