Cloveden 100 times higher concentrated
- Product NDC
- 84516-040
- 11-digit product format
- 845160040
- Labeler code
- 84516
- Product ID
- 84516-040_3c0e1862-2940-4d23-e063-6294a90a33e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetylpyridinium Chloride
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Acuseplanet Inc
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-01
- Substance
- CETYLPYRIDINIUM CHLORIDE
- Active strength
- 2.29 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cloveden 100 times higher concentrated
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETYLPYRIDINIUM CHLORIDE | 2.29 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| D9OM4SK49P | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2590919 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3c0e1862-293f-4d23-e063-6294a90a33e1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84516-040-01 | Cloveden 100 times higher concentrated | 50 mL in 1 BOTTLE | MOUTHWASH | 50 | 1 | |
| 84516-040-02 | Cloveden 100 times higher concentrated | 1 in 1 CARTON | MOUTHWASH | 1 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kids Flouride Rinse | SODIUM FLUORIDE | Your Military Exchanges | 5f6f4125-6264-4724-bb7e-a6e100939b41 | 2026-08-28 | Warnings, Adverse reactions | M021 |
| Colgate MaxFresh Clean Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 7cb85fc4-573b-45d7-a430-f2fd17320c43 | 2026-08-26 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 8b210b6c-b712-4f14-906c-306922573a26 | 2026-08-26 | Warnings | M021 |
| COLGATE 2IN1 ICY BLAST | SODIUM FLUORIDE | Colgate-Palmolive Company | 6aad9a91-ba1c-4a27-9269-ea8032feaad0 | 2026-08-26 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 59dff762-7f66-8bdc-e063-6294a90a9f18 | 2026-08-25 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Nice-Pak Products, LLC | c71d4064-f938-477b-9346-eb38be65390d | 2026-08-25 | Warnings, Adverse reactions | M021 |
| AIM Whitening with Baking Soda | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0fd0b4-33ba-5764-e054-00144ff88e88 | 2026-08-25 | Warnings | M021 |
| OPTIC WHITE PRO SERIES VIBRANT CLEAN | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | b1ada157-a9a0-4eec-83a2-6e448d7f12dc | 2026-08-21 | Warnings | M021 |
| Therabreath Whitening | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 3ba04b55-38f9-76f3-e063-6394a90a3c03 | 2026-08-21 | Warnings | M021 |
| Therabreath Deep Clean | STANNOUS FLUORIDE | Church & Dwight Co., Inc. | 3c372f26-e0c4-0659-e063-6294a90ae9f9 | 2026-08-21 | Warnings | M021 |
| TheraBreath | POTASSIUM NITRATE, SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 2026-08-21 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | eb95e0ca-a94c-41cb-9f54-6c64ed9a9733 | 2026-08-21 | Warnings, Adverse reactions | M021 |
| Pop On Toothpaste. | POP ON TOOTHPASTE. | POPONSMILES,LLC | 4a0edab5-ae36-91b5-e063-6294a90aa685 | 2026-08-21 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 188dc3ac-64c9-438e-858b-846f725c6ea0 | 2026-08-21 | Warnings | M021 |
| COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT | STANNOUS FLUORIDE | Colgate-Palmolive Company | 178d4535-fa57-4b53-b1f8-5c591f2ea9e7 | 2026-08-21 | Warnings | M021 |
| freshSTART Anticavity fluoride toothpaste. | ANTICAVITY FLUORIDE TOOTHPASTE | Guangzhou Xinuo Technology Co., Ltd. | 596432d5-3541-6dff-e063-6294a90a9d42 | 2026-08-19 | Warnings | M021 |
| Colgate Sensitive ProRelief Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | 8d9d485e-6efb-4bca-a779-9e8b0aeed14c | 2026-08-18 | Warnings | M021 |
| SprinJene Natural | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | e64cecc3-0845-4bdf-a449-d78248791ccf | 2026-08-17 | Warnings | M021 |
| ATOMY ANTICAVITY TOOTH | SODIUM MONOFLUOROPHOSPHATE | ATOMY CO., LTD. | 592caccc-e3a9-9c66-e063-6394a90a26e3 | 2026-08-16 | Warnings | M021 |
| SprinJene Health Boost | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 2026-08-14 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2590919 | cetylpyridinium chloride 2.3 % Concentrated Mouthwash | PSN | 3c0e1862-293f-4d23-e063-6294a90a33e1 | 1 |
| 2590919 | cetylpyridinium chloride 23 MG/ML Mouthwash | SCD | 3c0e1862-293f-4d23-e063-6294a90a33e1 | 1 |
| 2590919 | cetylpyridinium chloride 2.296 % Mouthwash | SY | 3c0e1862-293f-4d23-e063-6294a90a33e1 | 1 |
| 2590919 | cetylpyridinium chloride 2.3 % Mouthwash | SY | 3c0e1862-293f-4d23-e063-6294a90a33e1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84516-040-01 | 84516004001 | 50 mL in 1 BOTTLE | 50 ml | Historical | |||
| 84516-040-02 | 84516004002 | 1 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01) | 1 bottle | 2025-08-01 | No | No | Current |