Hismile
- Product NDC
- 83013-318
- 11-digit product format
- 830130318
- Labeler code
- 83013
- Product ID
- 83013-318_4878e7f3-6f6e-77be-e063-6394a90a9d8e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Strawberry Flavor Sodium Fluoride Anticavity Toothpaste
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Hismile Pty Ltd
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-15
- Substance
- SODIUM FLUORIDE
- Active strength
- 2.4 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hismile
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 2.4 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 416783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83013-318-06 | Hismile | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83013-318 | HISMILE (STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE) GEL [HISMILE PTY LTD] | 4 | Current NDC, 1 package rows | 20240713_0ef766ae-754a-f185-e063-6294a90a3299.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83013-318-06 | 83013031806 | 60 g in 1 BOTTLE, PUMP (83013-318-06) | 60 g | 2024-01-15 | No | No | Current |