Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habtis ( to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Anticavity
Aids in the prevention of dental cavities
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Water
Sorbitol
Glycerin
Hydrated Silica
Xylitol
Sodium Phosphate
Xanthan Gum
Sodium Lauroyl Sarcosinate
Tetrapotassium Pyrophosphate
1,2-Hexanediol
Cellulose Gum
Sucralose
Lauryl Glucoside
Methyl Diisopropyl Propionamide
Sodium Gluconate
Zinc Lactate
FD&C Blue No. 1.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 3 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 3 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 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 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83013-326-06 | HISMILE | 60 g in 1 BOTTLE, PUMP | GEL | 60 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83013-326 | 83013-326-06 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1de591d9-9cab-e63d-e063-6394a90ac8eb | 2026-01-15 | Warnings | 83013-326-06 83013-326 83013032606 4879b7a1-f8f7-92e6-e063-6394a90a41a5 1de591d9-9cab-e63d-e063-6394a90ac8eb |