SENSODYNE PRONAMEL
- Product NDC
- 0135-0450
- 11-digit product format
- 001350450
- Labeler code
- 0135
- Product ID
- 0135-0450_12df093e-d034-6f24-e063-6294a90acf44
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate and sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-04
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 50; 1.15 mg/g; 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
- SENSODYNE PRONAMEL
- Brand name suffix
- mineral BOOST refreshing peppermint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1.15 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
| Rxcui | 1086243 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0450-01 | SENSODYNE PRONAMELmineral BOOST refreshing peppermint | 1 in 1 CARTON | PASTE | 1 | | 2 |
| 0135-0450-01 | SENSODYNE PRONAMELmineral BOOST refreshing peppermint | 118 g in 1 TUBE | PASTE | 118 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0450 | SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240306_b6b53ab0-82ee-459a-be1a-14e12c2582f5.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 |
|---|
| 0135-0450-01 | 00135045001 | 1 TUBE in 1 CARTON (0135-0450-01) / 118 g in 1 TUBE | 1 tube | 2021-01-04 | 0000-00-00 | No | No | Current |