Sensodyne Pronamel
- Product NDC
- 0135-0810
- 11-digit product format
- 001350810
- Labeler code
- 0135
- Product ID
- 0135-0810_1fab5aa6-1081-c4f5-e063-6294a90a5d1c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate, sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-06
- 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
- Clinical Enamel Strength Deep Clean
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0810-01 | Sensodyne PronamelClinical Enamel Strength Deep Clean | 23 g in 1 TUBE | PASTE | 23 | | 1 |
| 0135-0810-02 | Sensodyne PronamelClinical Enamel Strength Deep Clean | 1 in 1 CARTON | PASTE | 1 | | 1 |
| 0135-0810-02 | Sensodyne PronamelClinical Enamel Strength Deep Clean | 96.4 g in 1 TUBE | PASTE | 96.4 | | 1 |
| 0135-0810-03 | Sensodyne PronamelClinical Enamel Strength Deep Clean | 1 in 1 CARTON | PASTE | 1 | | 1 |
| 0135-0810-03 | Sensodyne PronamelClinical Enamel Strength Deep Clean | 65.2 g in 1 TUBE | PASTE | 65.2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0810 | SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH DEEP CLEAN (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 1 | Current NDC, 5 package rows | 20250107_cfda7efa-86fa-470d-a79f-81907e31778a.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 |
|---|
| 0135-0810-01 | 00135081001 | 23 g in 1 TUBE (0135-0810-01) | 23 g | 2025-01-06 | No | No | Historical |
| 0135-0810-02 | 00135081002 | 1 TUBE in 1 CARTON (0135-0810-02) / 96.4 g in 1 TUBE | 1 tube | 2025-01-06 | No | No | Historical |
| 0135-0810-03 | 00135081003 | 1 TUBE in 1 CARTON (0135-0810-03) / 65.2 g in 1 TUBE | 1 tube | 2025-01-06 | No | No | Historical |