Clarben
- Manufacturer
- Dharma Research, Inc.
- Effective date
- 2021-07-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:37:18
Label at a glance#
ProductClarben
Active ingredientSODIUM FLUORIDE
Label structure1 sections
Label contents#
Full prescribing information#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53045-214-17 | Clarben | 490 g in 1 BOTTLE | GEL | 490 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Clarben
- Sodium Fluoride
- FLUORIDE ION
- WATER
- FD&C RED NO. 40
- SACCHARIN SODIUM
- SODIUM BENZOATE
- TITANIUM DIOXIDE
- .ALPHA.-TOCOPHEROL ACETATE
- CITRIC ACID MONOHYDRATE
- XYLITOL
- MAGNESIUM ALUMINUM SILICATE
- XANTHAN GUM
- PHOSPHORIC ACID
- HYDROFLUORIC ACID
- POLYSORBATE 20
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53045-214 | 53045-214-17 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| HYDROFLUORIC ACID | RGL5YE86CZ | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 16fee096-e8a2-4e7d-a6a6-67aa811baa92 | 755d80ff-33b2-4030-9a3e-7c2ec3147875 | 2021-07-02 | 16fee096-e8a2-4e7d-a6a6-67aa811baa92 755d80ff-33b2-4030-9a3e-7c2ec3147875 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
