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
Non-surgical Treatment of Peri-implant Mucositis	2019/04/16	NCT03915665	Not Applicable	Completed	I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Bacterial Decolonization to Prevent Radiation Dermatitis	2019/03/21	NCT03883828	Phase 2	Completed	Montefiore Medical Center
Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries	2019/03/01	NCT03859908	Phase 4	Terminated	Universidad de El Salvador
Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth	2019/02/26	NCT03855527	Phase 2	Completed	Nourhan M.Aly
Preoperative Dose of Co-amoxiclav for Prevention of Postoperative Complications in Dentoalveolar Surgery	2019/02/18	NCT03844776	Not Applicable	UNKNOWN	Taibah University
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions	2019/02/12	NCT03838575	Phase 3	UNKNOWN	University of Birmingham
Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist	2019/02/11	NCT03836781	Phase 2	Completed	Amirhossein Farahmand
Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension	2018/12/26	NCT03787082	Phase 1	Withdrawn	Gladwin, Mark, MD
Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients	2018/12/12	NCT03773094	Phase 2	UNKNOWN	Cairo University
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery	2018/11/15	NCT03741894	Phase 4	UNKNOWN	University of Pecs

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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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NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
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PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
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TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
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Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MICROBAN MEDICAL	noveko inc.	02286793	Gel - Topical (Household)	0.5 % / W/V	12/20/2006
E-Z SCRUB ANTIMICROBIAL FOAM SOLUTION CONTAINING 4% CHG	becton dickinson	02241362	Liquid - Topical	4.0 %	10/19/2000
DENTICARE CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12%	AMD Medicom Inc	02240526	Mouthwash - Buccal	0.12 %	11/26/1999
DEXIDIN LIQ 4%	laboratoire atlas inc	00832111	Solution - Topical	4 % / W/V	12/31/1990
CHLORAPREP	becton dickinson canada inc.	02484374	Solution - Topical	2 % / W/V	11/18/2019
BAXEDIN	omega laboratories limited	00788422	Solution - Topical	0.05 % / W/V	12/31/1989
SOLUPREP ANTISEPTIC SKIN CLEANSER SPONGE	3M Canada Company	01925202	Sponge - Topical (Hospital/HC Facilities)	4 % / W/V	12/31/1996
SANITAL ANTIBACTERIAL HAND SOAP	sanital chemical labs ltd.	02506017	Solution - Topical (Household)	2 % / W/W	N/A
SEAQUA X	seaford pharmaceuticals inc	02231830	Lotion - Topical	2.0 %	N/A
SALVESEPT CRM	protector canada inc.	01954091	Cream - Topical	1 %	12/31/1993

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
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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
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