Chlorhexidine Gluconate

Treats gingivitis as characterized. Sold as Hibiclens, Hibistat, Peridex, Dyna-Hex 4, Exidine and 8 more. Every FDA application for this active ingredient: 16 branded and 16 generic.

As of Nov 15, 2026, FDA lists 32 applications for Chlorhexidine Gluconate (sold as Hibiclens, Hibistat, Peridex and others), first approved Sep 17, 1976, with 4 new uses approved and 0 published complete response letters.

First approved: Sep 17, 1976
Applications: 32
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $15.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Chlorhexidine Gluconate	Part D	$15.3M	+12%	1,713,834
Periogard	Part D	$31K	+33%	4,654

Clinical Trials

186 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Silica-Based Wound Treatment (Curi01) Plus Standard Care Versus Standard Care Alone for Chronic Diabetic Foot WoundsDiabetic Foot Disease, Foot Ulcer Due to Type 1 Diabetes Mellitus · Cutempa Medical AG	Not applicable	Recruiting	Nov 13, 2026
Ultrasound-Guided Percutaneous Electrolysis Plus Exercise for Chronic Supraspinatus TendinopathySupraspinatus Tendinopathy, Rotator Cuff Tendinopathy · DAVID CRUZ DÍAZ	Not applicable	Enrolling by invitation	Nov 10, 2026
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers PatientsOzone Gel, Chlorohexidine Gel · October 6 University	Not applicable	Recruiting	Nov 6, 2026
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU PatientsCritical Illness, Pain · Sinop Atatürk State Hospital	—	Not yet recruiting	Nov 5, 2026
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot StudyTooth Loss and Rehabillitation, Dental Implant Failure · University of Medicine and Pharmacy at Ho Chi Minh City	Not applicable	Not yet recruiting	Nov 5, 2026
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After MastectomyBreast Cancer, Breast Cancer Female · Memorial Sloan Kettering Cancer Center	Phase 2	Recruiting	Nov 5, 2026
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced GingivitisPlaque-Induced Gingivitis · University of Sulaimani	Phase 2	Not yet recruiting	Oct 29, 2026
Oral Mucosal Grafting for Nasal Septal Perforation RepairNasal Septal Perforation · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	—	Not yet recruiting	Oct 29, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 17, 1976	HibiclensNDA 17768 · New active ingredient	Molnlycke Hlth	39	Marketed
May 23, 1980	HibistatNDA 18300 · New dosage form	Molnlycke Hlth	17	Marketed
Aug 27, 1981	HibiclensNDA 18423 · New formulation or manufacturer	Molnlycke Hlth	13	Discontinued
Dec 24, 1984	Dyna-Hex 4NDA 19125 · New dosage form	Xttrium	27	Marketed
Dec 24, 1984	ExidineNDA 19127 · New dosage form	Xttrium	13	Marketed
Dec 17, 1985	ExidineNDA 19421 · New dosage form	Xttrium	1	Discontinued
Dec 17, 1985	Dyna-Hex 2NDA 19422 · New dosage form	Xttrium	34	Marketed
Jul 22, 1986	Cida-Stat, Chg ScrubNDA 19258 · New formulation or manufacturer	Ecolab	17	Marketed
Jul 24, 1986	Steri-StatANDA 70104	Matrix Medcl	3	Discontinued
Aug 13, 1986	PeridexNDA 19028 · New dosage form	Solventum	15	Marketed
Dec 17, 1987	Brian CareANDA 71419	Soapco	9	Discontinued
Dec 2, 1988	Pharmaseal Scrub CareNDA 19793 · New formulation or manufacturer	Carefusion 2200	3	Discontinued
Mar 31, 1989	BioscrubNDA 19822 · New formulation or manufacturer	Griffen	5	Marketed
Oct 24, 1989	Chlorhexidine GluconateANDA 72525	Becton Dickinson	0	Marketed
Feb 28, 1991	MicrodermANDA 72295	J And J	0	Discontinued
Apr 15, 1991	MicrodermANDA 72255	J And J	5	Discontinued
Jan 28, 1992	Prevacare RANDA 72292	J And J	5	Discontinued
Jan 14, 1994	PeriogardANDA 73695	Colgate Palmolive Co	13	Discontinued
Dec 15, 1995	Chlorhexidine GluconateANDA 74522	Pharm Assoc	13	Marketed
Dec 28, 1995	Chlorhexidine GluconateANDA 74291	Lyne	4	Marketed
May 7, 1996	Chlorhexidine GluconateANDA 74356	Sciegen Pharms	5	Discontinued
Sep 11, 1997	Chlorhexidine GluconateNDA 20111 · New dosage form	Bajaj	5	Marketed
May 15, 1998	PeriochipNDA 20774 · New dosage form	Dexcel Pharma	10	Discontinued
Mar 14, 2000	E-Z ScrubANDA 73416	Becton Dickinson	0	Discontinued
Nov 14, 2000	Chlorhexidine GluconateANDA 75561	Bajaj	5	Marketed
Mar 3, 2004	Chlorhexidine GluconateANDA 75006	Chartwell Rx	0	Marketed
Apr 25, 2005	Chlorhexidine GluconateNDA 21669 · New dosage form	Sage Prods	13	Marketed
Nov 29, 2005	ParoexANDA 76434	Sunstar Americas	1	Discontinued
Jun 18, 2009	Chlorhexidine GluconateANDA 77789	Pharmobedient	2	Marketed
Jan 28, 2016	PeriogardANDA 203212	Colgate-Palmolive Co	1	Marketed
Nov 20, 2018	Readyprep ChgNDA 207964 · New formulation or manufacturer	Medline Industries	1	Marketed
—	Chlorhexidine GluconateNDA 19490	Kendall Il	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA