Overview

Chlorhexidine is a broad-spectrum antimicrobial biguanide used as a topical antiseptic and in dental practice for the treatment of inflammatory dental conditions caused by microorganisms. It is one of the most common skin and mucous membrane antiseptic agents in use today. The molecule itself is a cationic bis-guanide consisting of two 4-chlorophenyl rings and two biguanide groups joined by a central hexamethylene chain. Topical chlorhexidine for disinfection, as well as oral rinses for dental use, carries activity against a broad range of pathogens including bacteria, yeasts, and viruses. Chlorhexidine was developed in the UK by Imperial Chemical Industries in the early 1950s and was introduced to the US in the 1970s. The FDA withdrew its approval for the use of chlorhexidine gluconate topical tincture 0.5%, due to a significant number of reports concerning chemical and thermal burns associated with the use of this product. Other formulations of chlorhexidine continue to be available.

Indication

Chlorhexidine is available over-the-counter in various formulations (e.g. solution, sponge, cloth, swab) as a topical antiseptic to sanitize prior to surgeries and/or medical procedures. Dental formulations, available by prescription only, include an oral rinse indicated for the treatment of gingivitis and a slow-release "chip" which is inserted into periodontal pockets and is indicated for the reduction of pocket depth in adult patients with periodontitis as an adjunct therapy to dental scaling and root planing procedures.

Associated Conditions

Aphthous ulcer
Catarrh of the throat
Chemotherapy Induced Oral Mucositis
Chronic Wounds
Decubitus Ulcer
Dental Cavity
Dysphagia
Eczema infected
Foeter Ex Ore
Gingival Bleeding
Gingival Diseases
Gingivitis
Glossitis
Hoarseness
Infection
Infectious Periodontal Diseases
Injury Throat
Mild to Moderate Inflammatory Reaction of the Oral Cavity
Mild to Moderate Inflammatory Reaction of the Pharynx
Mouth injury
Mucositis
Neurodermatitis
Ocular Inflammation
Ocular Irritation
Oral Aphthous Ulcer
Pain
Periodontitis
Pharyngitis
Plaque, Dental
Postoperative Wound Infection
Purulent Gingivitis
Radiation Mucositis
Red eye
Ringworm
Skin Infections
Sore Throat
Stomatitis
Surgical Wounds
Tissue Damage
Tonsillitis
Ulcers, Leg
Wound Infections
Bacterial skin infections
Dry, cracked skin
Gum pain
Moderate Gingivitis
Oral infections
Oral lesions
Recurrent Oral fungal infection
Severe Gingivitis
Superficial Wounds
Throat disinfection
Tongue inflammation

Research Report

Published: Jul 21, 2025

An Expert Report on Chlorhexidine (DB00878): A Comprehensive Analysis of its Pharmacology, Clinical Utility, and Safety Profile

Executive Summary and Overview

Chlorhexidine, identified by DrugBank ID DB00878, is a broad-spectrum bisbiguanide antiseptic that has served as a cornerstone of infection control in both medical and dental practice for over seven decades.[1] Developed in the early 1950s by Imperial Chemical Industries in the United Kingdom, its well-established efficacy and robust safety profile have secured its inclusion on the World Health Organization's List of Essential Medicines, a testament to its critical role in health systems worldwide.[1] Its primary utility is derived from its potent and persistent antimicrobial activity against a wide range of pathogens, including Gram-positive and Gram-negative bacteria, yeasts, and certain enveloped viruses.[1] This has led to its formulation in a vast array of products, from over-the-counter topical solutions for skin disinfection and surgical hand scrubs to prescription-only oral rinses for the management of gingivitis.[1]

Continue reading the full research report

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Antiseptic Effects on the Dental Implant Internal Surface Microbiome	2021/08/27	NCT05024760	Early Phase 1	Recruiting	Madigan Army Medical Center
Baseline Oral Health Study: UnCoVer the Connections to General Health	2021/07/08	NCT04954313	Phase 4	Active, not recruiting	University of North Carolina, Chapel Hill
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients	2021/06/28	NCT04941131	Phase 4	Completed	King Abdulaziz University
A 96-hour Patch Test Study Using Healthy Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations	2021/06/28	NCT04942496	Phase 4	UNKNOWN	Molnlycke Health Care AB
Hyaluronic Acid in Counteracting Aphthous Stomatitis	2021/05/13	NCT04884464	N/A	Completed	University of Urbino "Carlo Bo"
Streptococcus Mutans Reduction Early Mother-infant Transmission	2021/05/03	NCT04868513	Phase 4	Completed	Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
Impact of Periodontal Therapy on Patients With Diabetes	2021/04/05	NCT04830969	Phase 2	Completed	State University of New York at Buffalo
Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter	2021/03/29	NCT04821193	Not Applicable	Completed	Istanbul University - Cerrahpasa (IUC)
Perioperative Patient Skin Antiseptic Preparation Evaluation	2021/02/16	NCT04756804	Phase 3	Completed	Zurex Pharma, Inc.
Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19	2021/02/10	NCT04748783	Phase 2	Terminated	University of North Carolina, Chapel Hill

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CliniClean	Xttrium Laboratories, Inc.	0116-0901	TOPICAL	4 g in 100 mL	4/30/2025
Periogard Alcohol Free	Colgate Oral Pharmaceuticals, Inc.	0126-0272	BUCCAL	1.2 mg in 1 mL	11/18/2020
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	Xttrium Laboratories, Inc.	0116-6720	ORAL	1.2 mg in 1 mL	9/6/2022
Chlorhexidine Gluconate	ATLANTIC BIOLOGICALS CORP.	17856-2002	ORAL	1.2 mg in 1 mL	3/26/2020
Chlorhexidine Gluconate	Atlantic Biologicals Corps	17856-2002	ORAL	1.2 mg in 1 mL	3/26/2020
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	Bajaj Medical, LLC	61037-469	DENTAL	1.2 mg in 1 mL	1/2/2024
MiconaHex plus Triz	Dechra Veterinary Products	17033-175	TOPICAL	20 mg in 1 mL	6/6/2025
Chlorhexidine Gluconate	Xttrium Laboratories, Inc.	0116-0101	ORAL	0.12 mg in 1 mL	3/23/2020
CHLORHEXIDINE GLUCONATE	H.J. Harkins Company, Inc.	76519-1067	ORAL	1.2 mg in 1 mL	8/27/2018
Antiseptic Skin Cleanser	Xttrium Laboratories, Inc.	0116-0137	TOPICAL	4 mg in 100 mL	4/30/2025

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SAVACOL ANTISEPTIC MOUTH & THROAT RINSE chlorhexidine gluconate 2 mg/mL mouthwash bottle - reformulation (alcohol free)	380414	Colgate-Palmolive Pty Ltd	Medicine	A	12/8/2021
EVOCLENS-4 4% CHG ANTISEPTIC SURGICAL SCRUB SOLUTION chlorhexidine gluconate 4 % w/w bottle	289014	Novapharm Research (Australia) Pty Ltd	Medicine	A	5/16/2017
SOLUPREP ANTISEPTIC SWAB SMALL (clear) medicated swab sachet	226779	KCI Medical Australia Pty Ltd	Medicine	A	8/11/2014
AVAGARD ANTISEPTIC CHG HAND RUB solution bottle	77398	KCI Medical Australia Pty Ltd	Medicine	A	2/12/2001
Chlorhexidine 0.015% and Cetrimide 0.15% Irrigation Solution	278536	Pfizer (Perth) Pty Ltd	Medicine	A	8/1/2016
Perrigo Surgi-Prep C+ Red solution bottle	319265	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	6/25/2019
SAVLON ANTISEPTIC CREAM tube	11247	Reckitt Benckiser Pty Ltd	Medicine	A	7/11/1991
SOOV cream tube	10620	Ego Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
SAVACOL ANTISEPTIC MOUTH & THROAT RINSE MINT chlorhexidine gluconate 2 mg/mL mouthwash bottle	11245	Colgate-Palmolive Pty Ltd	Medicine	A	7/11/1991
SOLUPREP ANTISEPTIC APPLICATOR solution	226780	KCI Medical Australia Pty Ltd	Medicine	A	8/11/2014

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SAVLON HOSPITAL CONCENTRATE	durex canada, division of ssl canada inc.	02021005	Liquid - Topical	1.5 %	12/31/1993
ANTISEPTIC FIRST AID SPRAY	wasip ltd.	02292491	Liquid - Topical	2 %	6/11/2007
AKILSPRAY HAND SANITIZER	delta pharma inc.	02499649	Spray - Topical (Household)	2 % / W/W	N/A
ULTRASTAT	wallace, cameron and company ltd.	00280704	Aerosol - Topical	.1 %	12/31/1973
PERIOGARD	colgate-palmolive canada inc	02207796	Mouthwash - Buccal	0.12 %	10/30/1996
CHLORHEXIDINE ALCOHOL FREE	euro-pharm international canada inc	02463032	Mouthwash - Buccal	0.12 % / W/V	2/20/2018
CHLORHEXIDINE 0.5% LIQ	bio-pharm inc.	00804622	Liquid - Topical	.5 %	12/31/1989
DEXIDIN 2 DETERGENT	laboratoire atlas inc	00832138	Solution - Topical	2 % / W/V	12/31/1990
LORIS 2% CHG SOLUTION	lernapharm (loris) inc.	02358018	Solution - Topical (Household)	2 % / W/V	7/10/2014
ANTISEPTIC BODY CLEANSER	Sage Products LLC	02245741	Wipe - Topical	2 %	2/14/2006

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.