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 |
|---|---|---|---|---|---|
2024/09/23 | Phase 3 | Completed | |||
2024/06/28 | Phase 3 | Completed | |||
2023/04/06 | Phase 4 | Completed | |||
2021/01/22 | Phase 4 | Completed | |||
2020/10/14 | Phase 2 | Terminated | |||
2018/10/16 | Phase 1 | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2017/07/18 | Phase 4 | Completed | |||
2017/06/07 | Phase 4 | UNKNOWN | University of Taubate | ||
2016/06/02 | Phase 2 | Completed | |||
2016/04/29 | Phase 2 | Completed | Islamic Azad University, Tehran |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Consumer Product Partners, LLC | 11344-900 | ORAL | 0.7 mg in 1 mL | 5/7/2025 | |
| Valu Merchandisers.Co | 63941-299 | ORAL | 0.7 mg in 1 mL | 5/20/2025 | |
| Topco Associates LLC | 36800-299 | ORAL | 0.7 mg in 1 mL | 5/27/2025 | |
| Rowpar Pharmaceuticals, Inc. | 58578-0407 | ORAL | 0.75 g in 1 mL | 5/16/2025 | |
| OraLabs | 63645-179 | TOPICAL | 1.11 g in 13 mL | 4/22/2025 | |
| Haleon US Holdings LLC | 0135-0652 | ORAL | 70 mg in 1 mL | 5/8/2025 | |
| WinCo Foods LLC | 67091-462 | ORAL | 0.7 mg in 1 mL | 5/22/2025 | |
| Old East Main. Co | 55910-299 | ORAL | 0.7 mg in 1 mL | 5/28/2025 | |
| Wal-Mart Stores, Inc | 49035-299 | ORAL | 0.7 mg in 1 mL | 6/2/2025 |
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 | SIN10428P | GEL | 0.01% w/w | 11/16/1998 | |
| DENTINOX TEETHING GEL | SIN04042P | GEL | 0.1% w/w | 3/28/1990 | |
| DIFFLAM ANTI-INFLAMMATORY LOZENGE (WITH ANTIBACTERIAL) (HONEY LEMON) | SIN12320P | LOZENGE | 1.33 mg | 6/13/2003 | |
| DIFFLAM ANTI-INFLAMMATORY LOZENGE (WITH ANTIBACTERIAL) (RASPBERRY RELIEF) | SIN12321P | LOZENGE | 1.33 mg | 6/13/2003 | |
| DIFFLAM MOUTH GEL | SIN09963P | GEL | 1 mg/g | 8/28/1998 | |
| Difflam™ Anti-inflammatory Lozenge (with antibacterial) (Eucalyptus and Menthol) | SIN13591P | LOZENGE | 1.33mg | 1/22/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cetylpyridinium Chloride Eye Drops | 国药准字H20060683 | 化学药品 | 眼用制剂(滴眼剂) | 1/22/2021 | |
| Cetylpyridinium Choloride Gargle Solution | 国药准字H20010365 | 化学药品 | 溶液剂 | 6/1/2020 | |
| Cetylpyridinium Choloride Gargle Solution | 国药准字H20113183 | 化学药品 | 含漱液 | 5/7/2021 | |
| Cetylpyridinium Choloride Gargle Solution | 国药准字H20010753 | 化学药品 | 含漱剂 | 9/20/2024 | |
| Cetylpyridinium Chloride Buccal Tablets | 国药准字H20253837 | 化学药品 | 片剂 | 4/8/2025 | |
| Cetylpyridinium Chloride Buccal Tablets | 国药准字H20123377 | 化学药品 | 片剂（含片） | 9/20/2022 | |
| Cetylpyridinium Chloride Buccal Tablets | 黄氏制药股份有限公司 | 国药准字HC20150051 | 化学药品 | 片剂 | 7/7/2020 |
| Cetylpyridinium Chloride Buccal Tablets | 国药准字H20052638 | 化学药品 | 片剂(口含片) | 5/11/2020 | |
| Cetylpyridinium Chloride Buccal Tablets | 黄氏制药股份有限公司 | 国药准字HC20150052 | 化学药品 | 片剂 | 7/7/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES DOUBLE MINT FLAVOUR | N/A | N/A | N/A | 1/12/2009 | |
| ORMECOL LOZENGES 2MG | N/A | N/A | N/A | 1/28/2010 | |
| DIFFLAM MOUTH GEL | N/A | N/A | N/A | 8/9/2004 | |
| DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (HONEY LEMON) | N/A | N/A | N/A | 6/22/2005 | |
| DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (ORANGE) | N/A | N/A | N/A | 6/22/2005 | |
| DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES EUCALYPTUS & MENTHOL FLAVOUR | N/A | N/A | N/A | 1/12/2009 | |
| DURO-TUSS CHESTY COUGH LOZENGES | N/A | N/A | N/A | 5/27/2022 | |
| DIFFLAM ANTI-INFLAM (W/ANTIBACT) S/F LOZ | N/A | 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 | Medicine | A | 4/27/1992 | |
| DIFFLAM ANTI-INFLAMMATORY + ANTIBACTERIAL raspberry flavour lozenge blister pack | 280644 | Medicine | A | 9/23/2016 | |
| XYOTUSS Chesty Cough lozenges Berry flavour blister pack | 379630 | Medicine | A | 11/30/2021 | |
| CEPACOL PLUS WITH ANAESTHETIC original flavour lozenge blister pack | 10097 | Medicine | A | 7/8/1991 | |
| DIFFLAM SORE THROAT FRESH MINT SUGAR FREE LOZENGES blister pack | 58319 | Medicine | A | 1/20/1997 | |
| PHARMACY SELECT BABY TEETHING GEL tube | 39770 | Medicine | A | 4/27/1992 | |
| BIOCOL MEDICATED THROAT LOZENGE orange | 42956 | Medicine | A | 4/2/1993 | |
| XYOTUSS Chesty Cough Lozenges Lemon Flavour blister pack | 379631 | Medicine | A | 11/30/2021 | |
| DUROFLAM Sore Throat Lozenges - Honey Lemon | 346982 | Medicine | A | 11/2/2020 | |
| DIFFLAM ANTI-INFLAMMATORY + ANTIBACTERIAL honey lemon flavour lozenge blister pack | 72150 | Medicine | A | 12/3/1999 |
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