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 |
|---|---|---|---|---|---|---|
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | 64f3d92d-f58c-4bc2-8819-f91492221ddb | 2026-03-02 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | c7b9e9cd-3cf7-4657-83c9-e221e1c35977 | 2026-03-02 | Warnings, Adverse reactions | M021 |
| Instant Whitening | INSTANT WHITENING TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 2807ece8-a1a5-b626-e063-6394a90aac62 | 2026-03-02 | Warnings | M021 |
| Coffe Tea Stain Remover Tooth | COFFE TEA STAIN REMOVER TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 2845d7af-7a0b-9bc8-e063-6294a90ac8b3 | 2026-03-02 | Warnings | M021 |
| Professional whitening tooth | PROFESSIONAL WHITENING TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 291eba71-14da-fac3-e063-6294a90aa3cc | 2026-03-02 | Warnings | M021 |
| purple tooth | PURPLE TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 291f0312-238c-71d5-e063-6294a90a39e1 | 2026-03-02 | Warnings | M021 |
| Professional Choice | PROFESSIONAL CHOICE TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 28406739-6a8c-1ce8-e063-6394a90a08f8 | 2026-03-02 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | 27a98b64-8369-4f3d-b487-d7ce98abc69f | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | 390dd1b5-2dd1-4b55-b4b3-e441ada61238 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | The Kroger Co. | 5459eeee-adf0-4afe-b190-62d4fa113806 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | The Kroger Co. | 932723b8-9875-4f37-8c11-018c94ae0ae1 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | d0c552d8-44ad-4d95-b3fb-17015f44b334 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Walmart Inc. | 3beb65e4-ae8e-4e51-b9ba-181cbec41eff | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | 61669087-0af6-4192-b514-afcfe7d8ba98 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Walmart Inc. | 1fd2f3ca-066e-282a-e063-6294a90a05a9 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | af5b93e7-5cce-4e01-8df2-54494d8b2910 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | 4590ca97-130c-46b2-9ba0-38f4703ef30a | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD. | 4ba81636-cdb7-e904-e063-6394a90a8bd5 | 2026-02-25 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Family Dollar Stores, Inc | 32a92add-c9db-4733-8e35-613825fdf081 | 2026-02-24 | Warnings, Adverse reactions | 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 |