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 |
|---|---|---|---|---|---|---|
| Colgate Cavity Protection Great Regular Flavor | ANTICAVITY FLUORIDE TOOTHPASTE | Colgate-Palmolive Company | 202c6c62-e16a-4716-babe-d5414006c79e | 2026-01-21 | Warnings | M021 |
| Crest 3D White Luxe Diamond Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c1420129-5460-4900-ac9a-356d2d7c60a2 | 2026-01-21 | Warnings | M021 |
| Crest Pro-Health Advanced Max Cavity and Erosion Prevention | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 48eb0bdc-7399-745d-e063-6294a90a9809 | 2026-01-21 | Warnings | M021 |
| Colgate Total Gum Protect Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3 | 2026-01-20 | Warnings | M021 |
| GuruNanda Anti-Cavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3b07b72f-4efc-eb0f-e063-6294a90a70a8 | 2026-01-19 | Warnings | M021 |
| GuruNanda Anticavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3e90d516-3172-3c8d-e063-6294a90a394f | 2026-01-19 | Warnings | M021 |
| Hismile | PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0eba92d1-cbdc-9c96-e063-6294a90a9afc | 2026-01-15 | Warnings | M021 |
| Hismile | COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3cfb6-6bae-1682-e063-6394a90aca88 | 2026-01-15 | Warnings | M021 |
| Hismile | MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7 | 2026-01-15 | Warnings | M021 |
| Hismile | SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef41051-dfa0-b105-e063-6294a90a551f | 2026-01-15 | Warnings | M021 |
| Hismile | WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef43107-58ec-d4ee-e063-6294a90ad8d7 | 2026-01-15 | Warnings | M021 |
| Hismile | RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef56539-dc21-c6ea-e063-6394a90a5790 | 2026-01-15 | Warnings | M021 |
| Hismile | GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef6f8b5-8565-b364-e063-6294a90aabbc | 2026-01-15 | Warnings | M021 |
| Hismile | STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef766ae-754a-f185-e063-6294a90a3299 | 2026-01-15 | Warnings | M021 |
| Hismile | BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef7be5b-df8f-9f32-e063-6394a90a4724 | 2026-01-15 | Warnings | M021 |
| Hismile | VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef8d0ef-a051-f610-e063-6394a90a8537 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d40b98b-2e9a-d84a-e063-6294a90a2096 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d44863e-93be-2b80-e063-6294a90a4a9d | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d458ccc-8f1e-f9c8-e063-6294a90a8da4 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d447939-fbf6-42f6-e063-6294a90af6d9 | 2026-01-15 | 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 |