Chloraprep One-Step Sepp, Chloraprep Single Swabstick, Chloraprep Triple Swabstick

NDA 21555, held by Becton Dickinson Co. Chlorhexidine Gluconate; Isopropyl Alcohol.

As of Nov 14, 2026, NDA 21555 (Chloraprep One-Step Sepp, Chloraprep Single Swabstick, Chloraprep Triple Swabstick), held by Becton Dickinson Co, was first approved by FDA on Oct 7, 2002, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 7, 2002
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 7, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Chloraprep One-Step Sepp2%;70% (0.67ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug
Chloraprep Single Swabstick2%;70% (1.75ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug
Chloraprep Triple Swabstick2%;70% (5.25ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug

All 15 submissions, including labeling and manufacturing supplements


Aug 30, 2023	Supplement 28Manufacturing	Approved	Label Letter
Dec 22, 2017	Supplement 20Manufacturing	Approved	Label
Sep 12, 2017	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 30, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Oct 10, 2013	Supplement 18Labeling · Standard review	Approved	Label Letter
Aug 16, 2012	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 16, 2012	Supplement 16Labeling · Standard review	Approved	Label Letter
Jul 20, 2010	Supplement 15Labeling · Standard review	Approved	Letter
Mar 2, 2010	Supplement 14Labeling · Standard review	Approved	None posted
Jun 10, 2009	Supplement 3Manufacturing	Approved	Letter
Aug 9, 2007	Supplement 9Manufacturing	Approved	Letter Label
Dec 20, 2006	Supplement 7Labeling · Standard review	Approved	Letter
Dec 27, 2005	Supplement 5Manufacturing	Approved	Letter
May 10, 2005	Supplement 1Manufacturing · Standard review	Approved	Letter
Oct 7, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21555
Drugs@FDA: Overview at FDA
Company: Becton Dickinson

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