Cetylpyridinium chloride

Overview

Cetylpyridinium is a quaternary ammonium with broad-spectrum antiseptic properties. Its salt form, cetylpyridinium chloride, is typically found as an active ingredient in mouthwashes, toothpastes, lozenges, throat sprays, breath sprays, and nasal sprays. In these products, it generally mediates an antiseptic activity and protective action against dental plaque and reducing gingivitis.

Indication

Typically employed as the cetylpyridinium chloride salt, this compound is commonly used as an active ingredient in various over-the-counter mouthwashes, toothpastes, lozenges, and mouth sprays where it is generally indicated for antiseptic actions, gingivitis and plaque prevention, as well as action or prevention against some other oropharyngeal bacterial infections .

Associated Conditions

Gingivitis
Oral Pain
Pain, Orofacial
Sore Throat
Stomatitis
Teething pain
Throat irritation
Dry cough
Gum pain
Oral discomfort and pain
Oral infections
Pain in throat
Throat infections
Throat inflammation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC)	2024/09/23	NCT06607172	Phase 3	Completed	Colgate Palmolive
Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses	2024/06/28	NCT06479226	Phase 3	Completed	Colgate Palmolive
Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets	2023/04/06	NCT05802628	Phase 4	Completed	Peking University People's Hospital
The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load	2021/01/22	NCT04721457	Phase 4	Completed	King Abdulaziz University
Mouth Rinses for Inactivation of COVID-19	2020/10/14	NCT04584684	Phase 2	Terminated	University of North Carolina, Chapel Hill
A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer	2018/10/16	NCT03706781	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis	2017/07/18	NCT03219840	Phase 4	Completed	The University of Texas Health Science Center, Houston
Mouthwashes During Orthodontic Treatment	2017/06/07	NCT03179735	Phase 4	UNKNOWN	University of Taubate
Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal	2016/06/02	NCT02788786	Phase 2	Completed	Johns Hopkins Bloomberg School of Public Health
A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases	2016/04/29	NCT02756377	Phase 2	Completed	Islamic Azad University, Tehran

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Antigingivitis/Antiplaque	Consumer Product Partners, LLC	11344-900	ORAL	0.7 mg in 1 mL	5/7/2025
Crest Pro-Health Advantage	The Procter & Gamble Manufacturing Company	69423-893	ORAL	0.07 g in 1 mL	7/31/2025
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	The Procter & Gamble Manufacturing Company	69423-856	ORAL	0.07 g in 1 mL	7/31/2025
Crest Pro-Health Gum Care	The Procter & Gamble Manufacturing Company	69423-864	ORAL	0.07 g in 1 mL	7/31/2025
ANTISEPTIC	Valu Merchandisers.Co	63941-299	ORAL	0.7 mg in 1 mL	5/20/2025
Antiseptic	Topco Associates LLC	36800-299	ORAL	0.7 mg in 1 mL	5/27/2025
CloSYS Silver Healthy Gums	Rowpar Pharmaceuticals, Inc.	58578-0407	ORAL	0.75 g in 1 mL	5/16/2025
Antigingivitis/Antiplaque	Meijer Distribution, INC	79481-0900	ORAL	0.7 mg in 1 mL	8/12/2025
CPH Anti-bacterial Breath Mist	OraLabs	63645-179	TOPICAL	1.11 g in 13 mL	4/22/2025
Crest Pro-Health Gum and Breath Purify	The Procter & Gamble Manufacturing Company	37000-949	ORAL	0.014 g in 20 mL	7/31/2025

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
SORAGEL ANTISEPTIC PAIN RELIEVING ORAL GEL	ICM PHARMA PTE. LTD.	SIN10428P	GEL	0.01% w/w	11/16/1998
DENTINOX TEETHING GEL	Dendron Brands Ltd	SIN04042P	GEL	0.1% w/w	3/28/1990
DIFFLAM ANTI-INFLAMMATORY LOZENGE (WITH ANTIBACTERIAL) (HONEY LEMON)	Unique Pharmaceuticals Laboratories	SIN12320P	LOZENGE	1.33 mg	6/13/2003
DIFFLAM ANTI-INFLAMMATORY LOZENGE (WITH ANTIBACTERIAL) (RASPBERRY RELIEF)	Unique Pharmaceuticals Laboratories	SIN12321P	LOZENGE	1.33 mg	6/13/2003
DIFFLAM MOUTH GEL	Ensign Laboratories Pty Ltd	SIN09963P	GEL	1 mg/g	8/28/1998
Difflam™ Anti-inflammatory Lozenge (with antibacterial) (Eucalyptus and Menthol)	Unique Pharmaceuticals Laboratories	SIN13591P	LOZENGE	1.33mg	1/22/2009

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
DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES DOUBLE MINT FLAVOUR	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	1/12/2009
ORMECOL LOZENGES 2MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	1/28/2010
DIFFLAM MOUTH GEL	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	8/9/2004
DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (HONEY LEMON)	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	6/22/2005
DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (ORANGE)	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	6/22/2005
DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES EUCALYPTUS & MENTHOL FLAVOUR	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	1/12/2009
DURO-TUSS CHESTY COUGH LOZENGES	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	5/27/2022
DIFFLAM ANTI-INFLAM (W/ANTIBACT) S/F LOZ	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	8/14/1998

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ORAPLEX COLD SORE GEL	39772	Petrus Pharmaceuticals Pty Ltd	Medicine	A	4/27/1992
DIFFLAM ANTI-INFLAMMATORY + ANTIBACTERIAL raspberry flavour lozenge blister pack	280644	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	9/23/2016
XYOTUSS Chesty Cough lozenges Berry flavour blister pack	379630	Mapaex Consumer Healthcare (Australia) Pty Ltd	Medicine	A	11/30/2021
CEPACOL PLUS WITH ANAESTHETIC original flavour lozenge blister pack	10097	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	7/8/1991
DIFFLAM SORE THROAT FRESH MINT SUGAR FREE LOZENGES blister pack	58319	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	1/20/1997
PHARMACY SELECT BABY TEETHING GEL tube	39770	Petrus Pharmaceuticals Pty Ltd	Medicine	A	4/27/1992
BIOCOL MEDICATED THROAT LOZENGE orange	42956	Nestle Australia Ltd	Medicine	A	4/2/1993
XYOTUSS Chesty Cough Lozenges Lemon Flavour blister pack	379631	Mapaex Consumer Healthcare (Australia) Pty Ltd	Medicine	A	11/30/2021
DUROFLAM Sore Throat Lozenges - Honey Lemon	346982	Mapaex Consumer Healthcare (Australia) Pty Ltd	Medicine	A	11/2/2020
DIFFLAM ANTI-INFLAMMATORY + ANTIBACTERIAL honey lemon flavour lozenge blister pack	72150	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	12/3/1999

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PULMOSIRUM PASTILLE	nutribon (1986) inc.	01912461	Lozenge - Oral	1.3 MG / LOZ	12/31/1994
XYLOCAINE ORAL SPRAY	astra pharma inc.	00001945	Aerosol - Topical , Oral	10 MG / 62.5 G	12/31/1965
FLUORIDE MOUTHWASH	national care products ltd.	01988115	Mouthwash/Gargle - Oral	.05 %	12/31/1993
CREST PRO-HEALTH MULTI PROTECTION	procter & gamble inc	02268884	Mouthwash - Buccal	0.07 % / W/W	11/9/2007
CREST PRO-HEALTH INVIGORATING CLEAN MULTI-PROTECTION	procter & gamble inc	02375028	Mouthwash - Buccal	0.07 % / W/W	7/23/2012
PERIOGARD PROTECT CETYLPYRIDINIUM CHLORIDE MOUTHWASH	colgate-palmolive canada inc	02542617	Mouthwash - Buccal	0.075 % / W/W	7/12/2024
CREST PRO-HEALTH FOR LIFE MULTI-PROTECTION	procter & gamble inc	02386631	Mouthwash - Buccal	0.07 % / W/W	8/5/2013
ORAL PLAN ANTIBACTERIAL MOUTHRINSE WITH FLUORIDE	ABBOTT LABORATORIES, LIMITED	02209160	Liquid - Dental	.025 %	5/28/1999
PASTILLES MEROL	produits francais labs inc.	00328669	Lozenge - Oral	.1625 MG	12/31/1975
HELLO CLEAN MINT	colgate-palmolive canada inc	02448068	Mouthwash - Dental	0.075 % / W/W	N/A

CIMA AEMPS Drug Approvals

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

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.

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