OTC - ACTIVE INGREDIENT SECTION
Sodium fluoride 0.243% (0.15% w/v fluoride ion)
Sodium fluoride 0.243% (0.15% w/v fluoride ion)
water, sorbitol, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1
Anticavity
aids in the prevention of dental cavities
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor • instruct children under 6 years of age in good brushing habits (to minimize swallowing) • supervise children as necessary until capable of using without supervision • children under 2 years of age: Consult a dentist or doctor
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 79903-282 | 79903-282-87, 79903-282-97 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| SORBITOL | 506T60A25R | IACT |
| SODIUM ACID PYROPHOSPHATE | H5WVD9LZUD | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MICA | V8A1AW0880 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-11-13 | full-release | 2026-06-01 01:15:58 |
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 |
|---|---|---|---|---|---|---|
| 437fb2ff-88e6-936e-e063-6294a90a9d4b | 1e647d52-9f87-2278-e063-6394a90aafa0 | 2025-11-13 | Warnings | 1e647d52-9f87-2278-e063-6394a90aafa0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.