Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing 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.
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Anticavity
Aids in the prevention of dental cavities
Do not swallow
Do not use in eye area
If more than used for brushing is 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 a day, or as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing 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.
Water
Sorbitol
Hydrated Silica
Glycerin
Xylitol
Disodium Phosphate
Sucralose
Sodium Lauroyl Sarcosinate
Xanthan Gum
Cellulose Gum
Flavor
Tetrapotassium Pyrophosphate
Caprylyl Glycol
Benzyl Alcohol
Menthol
Sodium Gluconate
Pentylene Glycol
Zinc Lactate
Benzoic Acid
Methyl Diisopropyl Propionamide
Titanium Dioxide
| 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 |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 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 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44038-0327-1 | HISMILE | 60 g in 1 BOTTLE, PUMP | GEL | 60 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44038-0327 | HISMILE (CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE) GEL [ACCUPAC LLC] | 3 | 1 package rows | 20240921_227a8e50-e79d-0e9c-e063-6394a90a4a21.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44038-0327 | 44038-0327-1 |
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 |
|---|---|---|---|---|---|---|
| 2268fd40-b8bb-ed1f-e063-6394a90a8001 | 227a8e50-e79d-0e9c-e063-6394a90a4a21 | 2024-09-18 | Warnings | 2268fd40-b8bb-ed1f-e063-6394a90a8001 227a8e50-e79d-0e9c-e063-6394a90a4a21 |
Adverse event summaries are temporarily unavailable. Other product information remains available.