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 |
|---|---|---|---|---|---|---|
| Optimax Anticavity Fluoride Raspberry | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 57e1d1cb-da58-4cd2-b960-4056e0b0d214 | 2026-06-05 | Warnings | M021 |
| 3ECARE Dual FormulaWhiteningToothpaste | SODIUM FLUORIDE | Hangzhou Namei Zhikang Technology Co., Ltd. | 533fb7dd-7f84-59c5-e063-6394a90accad | 2026-06-02 | Warnings | M021 |
| 3ECARE Dual FormulaToothpastefor sensitiveteeth | POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE | Hangzhou Namei Zhikang Technology Co., Ltd. | 533fc83e-a8cf-15c1-e063-6294a90a7b74 | 2026-06-02 | Warnings | M021 |
| Walgreens Restore and Defend | STANNOUS FLUORIDE | Walgreens | e808ea4b-9081-085b-e053-2a95a90a4f9b | 2026-06-02 | Warnings | M021 |
| Hello Unicorn Splash unicorn splash anticavity fluoride rinse | SODIUM FLUORIDE | Colgate-Palmolive Company | a1014431-7d23-aaff-6dc7-ab58683d0338 | 2026-06-02 | Warnings | M021 |
| Therabreath Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | feab3d45-ff95-4b32-8258-7d932a7380c9 | 2026-06-01 | Warnings | M021 |
| Orajel Toy Story 5 Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b80947d-f389-2f80-e063-6294a90abd55 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 54113245-0c1e-739e-e063-6294a90aea42 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 545258fd-8179-fffc-e063-6394a90a467f | 2026-06-01 | Warnings | M021 |
| Orajel Paw Patrol | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d87bea-3e99-5d04-e053-2a95a90aaf54 | 2026-06-01 | Warnings | M021 |
| Orajel SuperMario | ANTICAVITY TOOTHPASTE | Church & Dwight Co., Inc. | 27d2f6cb-8661-da9c-e063-6394a90a5bde | 2026-06-01 | Warnings | M021 |
| Orajel KidsToothpaste | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d62125-c2c5-5926-e053-2995a90aaa29 | 2026-06-01 | Warnings | M021 |
| AIM CAVITY PROTECTION Multi Benefit | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0f8a33-0b01-40e2-e054-00144ff88e88 | 2026-06-01 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 560980ea-749f-593d-e063-6394a90a1b9e | 2026-06-01 | Warnings | M021 |
| Colgate Revitalizing White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | c67223ae-b068-41c5-a15b-7ae9840b93ef | 2026-05-27 | Warnings | M021 |
| Colgate Kids Harry Potter | SODIUM FLUORIDE | Colgate-Palmolive Company | 61c06da4-9f02-4fbc-b80f-1c443e298496 | 2026-05-26 | Warnings | M021 |
| sodium fluoride rinse | SODIUM FLUORIDE RINSE | Rockland Cosmetics, Inc. | 52430b12-4d5f-d1e1-e063-6394a90abd64 | 2026-05-20 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | H E B | d0a52519-3339-40ea-93e5-78f76d348a4d | 2026-05-14 | Warnings, Adverse reactions | M021 |
| Burts Bees Extra White | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c92524fd-8b93-592d-e053-2a95a90a88c6 | 2026-05-13 | Warnings | M021 |
| MIPaste Plus Strawberry | SODIUM FLUORIDE | GC America Inc. | 1b68bd67-65d3-4c64-e054-00144ff8d46c | 2026-05-12 | 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 |