biotene
- Product NDC
- 0135-0577
- 11-digit product format
- 001350577
- Labeler code
- 0135
- Product ID
- 0135-0577_c26f08a5-fa67-417e-8499-015edb65f7f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium monofluorophosphate
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-09-01
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1.4 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM MONOFLUOROPHOSPHATE | 1.4 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C810JCZ56Q |
| Rxcui | 545626 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0577-01 | biotene | 1 in 1 CARTON | PASTE | 1 | | 9 |
| 0135-0577-01 | biotene | 121.9 g in 1 TUBE | PASTE | 121.9 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0577 | BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE [HALEON US HOLDINGS LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241107_a47a6502-efb2-4072-9562-cbe293531c2b.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 |
|---|
| 0135-0577-01 | 00135057701 | 1 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE | 1 tube | 2016-09-01 | 0000-00-00 | No | No | Current |