HISMILE
- Product NDC
- 83013-325
- 11-digit product format
- 830130325
- Labeler code
- 83013
- Product ID
- 83013-325_4879a9d4-38a4-34b5-e063-6394a90a152b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- HISMILE PTY LTD
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-15
- Substance
- SODIUM FLUORIDE
- Active strength
- .243 g/100g
- 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 | .243 g/100g |
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 |
|---|
| 83013-325-06 | HISMILE | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83013-325 | HISMILE (SODIUM FLUORIDE) GEL [HISMILE PTY LTD] | 2 | Current NDC, 1 package rows | 20240724_1d458ccc-8f1e-f9c8-e063-6294a90a8da4.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 |
|---|
| 83013-325-06 | 83013032506 | 60 g in 1 BOTTLE, PUMP (83013-325-06) | 60 g | 2024-07-15 | No | No | Current |