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

Title	Posted	Study ID	Phase	Status	Sponsor
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal	2025/08/26	NCT07142408	Not Applicable	Recruiting	The Cooper Health System
COMPARISON OF CLINICAL EFFECTS OF LISTERINE AND CHLORHEXIDINE MOUTH WASH IN PATIENTS UNDERGOING FIXED ORTHODONTIC TREATMENT	2025/08/13	NCT07119840	Not Applicable	Recruiting	Khyber Medical University Peshawar
Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain	2025/07/10	NCT07058727	Not Applicable	Not yet recruiting	Cukurova University
Irrisept in Emergency General Surgery Patients	2025/07/03	NCT07048899	Not Applicable	ENROLLING_BY_INVITATION	The University of Texas Health Science Center at Tyler
Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis	2025/04/20	NCT06936475	Not Applicable	Completed	Federal Teaching Hospital Abakaliki
Chlorhexidine Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis	2025/02/19	NCT06834711	Not Applicable	Completed	Cukurova University
Comparison of Effectiveness of Disinfectants	2025/02/06	NCT06811779	Phase 1	Completed	Armed Forces Institute of Dentistry, Pakistan
Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail	2025/01/15	NCT06775392	Phase 1	Completed	Krishnadevaraya College of Dental Sciences & Hospital
Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Established Dental Plaque and Gingivitis	2024/12/13	NCT06732466	Phase 3	Completed	Colgate Palmolive
The Effect of Two Different Oral Care Solutions on the Prevention of Ventilator-associated Pneumonia in the Intensive Care Unit	2024/12/13	NCT06733090	Not Applicable	Active, not recruiting	MELEK UNLUGEDIK

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Chlorhexidine Gluconate	Proficient Rx LP	63187-524	ORAL	1.2 mg in 1 mL	1/1/2021
DASH Chlorhexidine Gluconate 0.12% Oral Rinse	Natco Pharma USA LLC	69339-138	ORAL	1.2 mg in 1 mL	10/30/2023
CHLORHEXIDINE GLUCONATE	Lyne Laboratories, Inc.	0374-5080	ORAL	1.2 mg in 1 mL	1/2/2019
Chlorhexidine Gluconate	Lohxa	70166-027	ORAL	1.2 mg in 1 mL	2/25/2021
ANTISEPTIC SKIN CLEANSER	Xttrium Laboratories, Inc.	0116-1061	TOPICAL	4 g in 100 mL	4/30/2025
Periogard Alcohol Free	ATLANTIC BIOLOGICALS CORP.	17856-0272	BUCCAL	1.2 mg in 1 mL	3/1/2022
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	Henry Schein, Inc.	0404-0178	DENTAL	1.2 mg in 1 mL	2/28/2023
Chlorhexidine Gluconate Oral Rinse	Rising Pharma Holdings, Inc.	16571-128	DENTAL	1.2 mg in 1 mL	8/28/2023
Major Oral Rinse	Major Pharmaceuticals	0904-7035	ORAL	1.2 mg in 1 mL	11/23/2022
Chlorhexidine Gluconate	VistaPharm, LLC	66689-106	BUCCAL	1.2 mg in 1 mL	2/8/2024

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HORF LOZENGES	Y S P INDUSTRIES (M) SDN BHD	SIN08535P	LOZENGE	5 mg	2/5/1996
SILVIN CREAM	ICM PHARMA PTE. LTD.	SIN10131P	CREAM	0.2% w/v	10/2/1998
PerioChip	Dexcel Pharma Technologies Ltd	SIN13278P	LINER, DENTAL	2.50 mg	5/21/2007
ORAL AID LOTION	BEACONS PHARMACEUTICALS PTE LTD	SIN04696P	LOTION	0.5% w/v	6/13/1990
SOOV CREAM	EGO PHARMACEUTICALS PTY LTD	SIN08901P	CREAM	0.2% w/w	9/4/1996
DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION	Ensign Laboratories Pty Ltd	SIN08671P	MOUTHWASH	18 mg/15 ml	4/24/1996

NMPA Drug Approvals

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

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
COMFORDYL MOUTH WASH 0.2% W/V	N/A	MEDIPHARMA	N/A	N/A	10/20/2005
SOLUPREP ANTISEPTIC LARGE WIPE	N/A	3 m hong kong ltd	N/A	N/A	12/23/2024
QUALIDYL COLOR-FREE MOUTHRINSE 0.2% W/V	N/A	QUALITY PHARMA LAB	N/A	N/A	2/15/2008
QUALIKIN 0.2%W/V MOUTHWASH	N/A	QUALITY PHARMA LAB	N/A	N/A	12/11/1996
NEO-GUARD MOUTHWASH 0.2%	N/A	MEDIPHARMA	N/A	N/A	11/28/2002
MARSEPT CUTANEOUS SOLUTION 2% W/V + 70% V/V	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	4/19/2024
CHLORHEXIDINE SOLUTION 2% W/V IN ALCOHOL 70% V/V	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	5/29/2020
CORSODYL DENTAL GEL 1% W/W	N/A	Haleon Hong Kong Limited	N/A	N/A	6/6/1979
PORTLAND ANTISEPTIC GARGLE 0.2%	N/A	MEDIPHARMA	N/A	N/A	8/15/2002
ATALA MOUTHWASH 0.2%	N/A	MEDIPHARMA	N/A	N/A	7/26/2002

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CHLORHEXIDINE 0.5% IN ALCOHOL 70% SOLUTION bottle	11339	Pfizer Australia Pty Ltd	Medicine	A	8/13/1991
Bridgewest CHLORHEXIDINE 0.2% CATHETER PREP Irrigation Solution ampoule	11324	Bridgewest Perth Pharma Pty Ltd	Medicine	A	8/13/1991
CHLORHEXIDINE PRE-OP chlorhexidine gluconate 40mg/mL application tube	11329	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	8/13/1991
MICROSHIELD 4 CHLORHEXIDINE SURGICAL HANDWASH chlorhexidine gluconate 40mg/mL topical solution bag	47524	Schulke Australia Pty Ltd	Medicine	A	1/12/1994
CHLOROFLUOR GEL bottle	21505	Professional Dentist Supplies Pty Ltd	Medicine	A	10/8/1991
Chlorhexidine Irrigation Solution 0.1%	279137	Pfizer (Perth) Pty Ltd	Medicine	A	8/15/2016
MICROSHIELD 2 SOLUTION	447946	Schulke Australia Pty Ltd	Medicine	A	5/7/2024
HYGI-PREP ANTIMICROBIAL WASH 4% chlorhexidine gluconate 4% w/v solution tube	476325	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	1/22/2025
PERIO PACK	91660	Professional Dentist Supplies Pty Ltd	Medicine	A	11/5/2002
Bridgewest CHLORHEXIDINE 0.05% CETRIMIDE 0.5% irrigation solution ampoule	57011	Bridgewest Perth Pharma Pty Ltd	Medicine	A	9/4/1996

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CHLORHEXIDINE GLUCONATE SOLUTION USP 20%	Germiphene Corporation	02053632	Solution - Topical	20 % / W/V	12/31/1994
ANTISEPTIC CLEANSER SOLUTION	niagara pharmaceuticals inc.	02229377	Solution - Topical	2 %	8/20/1996
CHLORAPREP LIQ 0.5%	medi-flex inc.	02055694	Liquid - Topical	0.5 %	12/31/1994
HIBITANE SKIN CLEANSER	zoetis canada inc	00245097	Solution - Topical	4 % / W/V	12/31/1972
FLAMAZINE C	Smith & Nephew Inc	00714917	Cream - Topical	2 MG / G	12/31/1987
GERMI STAT GEL 4%	Germiphene Corporation	01930087	Gel - Topical	4 %	12/31/1992
DEXIDIN 20	laboratoire atlas inc	00832030	Solution - Topical	20 %	12/31/1989
CHLORHEXIDINE-CETRIMIDE SOLTN CONC	bio-pharm inc.	00806269	Liquid - Topical	1.5 %	12/31/1989
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP	xttrium laboratories inc.	02432579	Liquid , Mouthwash/Gargle - Oral	0.12 % / W/W	N/A
CALGON VESTAL 2% CHG ANTIMICROB.SKIN CLEANS.	calgon vestal laboratories inc.	02040255	Liquid - Topical	2 %	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CRISTALMINA PLUS 20 MG/ML + 0,70 ML/ML SOLUCIÓN PARA PULVERIZACIÓN CUTÁNEA	Laboratorios Salvat S.A.	88469	SOLUCIÓN PARA PULVERIZACIÓN CUTÁNEA	Sin Receta	Commercialized

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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

Related News

Chlorhexidine-Impregnated Central Venous Catheters Reduce ICU Bloodstream Infections by 70.5% in Multinational Study

3 months ago

A multinational prospective cohort study of over 6,670 ICU patients across eight countries demonstrated a 70.5% reduction in central line-associated bloodstream infections (CLABSIs) with chlorhexidine-impregnated catheters compared to plain catheters.

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