BIOTENE
- Product NDC
- 0135-0558
- 11-digit product format
- 001350558
- Labeler code
- 0135
- Product ID
- 0135-0558_95462fd1-5eb4-46ff-bf63-a5e610337bc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-15
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.5 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BIOTENE
- Brand name suffix
- Gentle Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 1.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 416783, 1044547 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0558-01 | BIOTENEGentle Mint | 1 in 1 CARTON | PASTE | 1 | | 10 |
| 0135-0558-01 | BIOTENEGentle Mint | 121.9 g in 1 TUBE | PASTE | 121.9 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0558 | BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241107_1101c17f-c848-4cd5-a7cd-679b59dbe1bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0135-0558-01 | 00135055801 | 1 TUBE in 1 CARTON (0135-0558-01) / 121.9 g in 1 TUBE | 1 tube | 2013-07-15 | 0000-00-00 | No | No | Current |