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CIDA-STAT

NDA

CHLORHEXIDINE GLUCONATE | N019258 | ECOLAB INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

328 trials from ClinicalTrials.gov — 18 recruiting, 2 active, 238 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement NCT06489431	Phase 3	Active	Rush University Medical Center	200	2023-12-04 → 2027-12-31
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate and Polyether Ether Ketone Denture Base Materials NCT07672847	N/A	By Invitation	Menoufia University	88	2026-01-31 → 2026-10-30
Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients NCT07791238	Phase 1/2	Not Yet Recruiting	Cairo University	63	2026-09-30 → 2027-10-30
Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances NCT07710144	N/A	Not Yet Recruiting	Plovdiv Medical University	90	2026-09-01 → 2028-05-31
Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.NCT07706387	N/A	Not Yet Recruiting	Ain Shams University	42	2026-07 → 2026-08
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery NCT07794280	N/A	Not Yet Recruiting	University of Medicine and Pharmacy at Ho Chi Minh City	20	2026-08 → 2027-09
Silver Nanoparticle vs Chlorhexidine Mouthwashes for Reducing Streptococcus Mutans and Improving Salivary pH in Children NCT07728409	N/A	Not Yet Recruiting	Assiut University	96	2026-08-05 → 2026-10-20
Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement NCT07696156	N/A	Not Yet Recruiting	diana garcia	202	2027-01-15 → 2029-01-12
ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation NCT07669064	N/A	Not Yet Recruiting	University Hospital Ulm	60	2026-06-20 → 2027-05-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$0.0411

per ml

Lowest NADAC/Unit

$0.0184

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
16571011112CHLORHEXIDINE 4% LIQUID	$0.0411	ML	Generic	—	2026-08-19
16571011124CHLORHEXIDINE 4% LIQUID	$0.0304	ML	Generic	—	2026-08-19
16571011148CHLORHEXIDINE 4% LIQUID	$0.0184	ML	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$3.53

Highest Price

$6.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16571-0111-12CHLORHEXIDINE GLUCONATE 4% LIQUID,TOP	$3.53	FSS	Rising Pharma Holding, Inc	05/31/2026
16571-0111-24CHLORHEXIDINE GLUCONATE 4% LIQUID,TOP	$5.31	FSS	Rising Pharma Holding, Inc	05/31/2026
16571-0111-48CHLORHEXIDINE GLUCONATE 4% LIQUID,TOP	$6.37	FSS	Rising Pharma Holding, Inc	05/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain9 active DMFs18 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

XTTRIUM LABORATORIES INCCHLORHEXIDINE GLUCONATE 20% SOLUTION USP

DMF 57821985

FAR SPECIALTY PRODUCTS INC DBA FAR CHEMICALCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 191282006

CADILA PHARMACEUTICALS LTDCHLORHEXIDINE GLUCONATE SOLUTION USP

DMF 195832006

RN LABORATORIES PVT LTDCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 219462008

MEDICHEM SACHLORHEXIDINE GLUCONATE SOLUTION (DGLP)

DMF 251492011

GARONIT PHARMACEUTICALS INCCHLORHEXIDINE GLUCONATE SOLUTION USP 20%

DMF 254172011

AVA INCCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 262132012

SMAART PHARMACEUTTICALSCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 353332021

HUNAN LIJIE BIOCHEMICAL CO LTDCHLORHEXIDINE GLUCONATE

DMF 373942022

SSL INTERNATIONALInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 17101971

ZENECA PHARMACEUTICALSInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION B.P.

DMF 30031977

ORION CORP LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP 20%

DMF 32901978

LONZA INCInactiveCHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE

DMF 40121980

WHITMOYER LABS INCInactiveCHLORHEXIDINE (BASE, DIHYDROCHLORIDE, GLUCONATE AND DIACETATE)

DMF 54531984

DELTA SYNTHETIC CO LTDInactiveCHLORHEXIDINE GLUCONATE (BULK)

DMF 59301985

ALCOLAC INCInactiveCHLORHEXIDINE GLUCONATE

DMF 69871987

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 83631989

DEGUSSA AG WERK RADEBEULInactiveCHLORHEXIDINE

DMF 84511990

MEDICHEM SAInactiveCHLORHEXIDINE GLUCONATE

DMF 97011992

ARZNEIMITTELWERK DRESDEN GMBHInactiveCHLORHEXIDINE (BASE)

DMF 114651995

THATCHER COInactiveCHLORHEXIDINE GLUCONATE, 20% (W/V)

DMF 124921997

ROHIT PLASTICS AND CHEMICALSInactiveCHLORHEXIDINE GLUCONATE 20%

DMF 162062002

BASIC PHARMA CHEMInactiveCHLORHEXIDINE GLUCONATE (BP)

DMF 173012004

GLIDE CHEM PVT LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION 20%

DMF 175592004

BASIC PHARMA LIFE SCIENCE PVT LTDInactiveCHLORHEXIDINE GLUCONATE

DMF 218782008

VIPOR CHEMICALS PRIVATE LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 230192009

DISHMAN CARBOGEN AMCIS LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 332382018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 11, 2018	SUPPL -26	View Letter (PDF)
Jan 15, 2016	SUPPL -23	View Letter (PDF)
Aug 10, 2015	SUPPL -21	View Letter (PDF)
May 21, 2012	SUPPL -19	View Letter (PDF)
Apr 28, 2010	SUPPL -16	View Letter (PDF)
Apr 7, 2006	SUPPL -14	View Letter (PDF)
Feb 17, 2005	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 4%

0 patents0 exclusivities▾

SOLUTION;TOPICAL | Approved: Jul 22, 1986

#001 — 2%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Jul 22, 1986

No patent or exclusivity listings for this strength.