Sensodyne Pronamel
- Product NDC
- 0135-0580
- 11-digit product format
- 001350580
- Labeler code
- 0135
- Product ID
- 0135-0580_ae922167-f3d1-461d-9233-114b01b349c1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate and sodium fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-15
- 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
- Gentle Whitening Advanced
- 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 |
|---|
| 0135-0580-01 | Sensodyne PronamelGentle Whitening Advanced | 184 g in 1 TUBE | PASTE | 184 | | 5 |
| 0135-0580-01 | Sensodyne PronamelGentle Whitening Advanced | 1 in 1 CARTON | PASTE | 1 | | 5 |
| 0135-0580-02 | Sensodyne PronamelGentle Whitening Advanced | 4 in 1 CARTON | PASTE | 4 | | 5 |
| 0135-0580-02 | Sensodyne PronamelGentle Whitening Advanced | 184 g in 1 TUBE | PASTE | 184 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0580 | SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240906_94e07979-943b-45bb-8e2b-90d686f3692e.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 |
|---|
| 0135-0580-01 | 00135058001 | 1 TUBE in 1 CARTON (0135-0580-01) / 184 g in 1 TUBE | 1 tube | 2021-03-15 | 0000-00-00 | No | No | Current |
| 0135-0580-02 | 00135058002 | 4 TUBE in 1 CARTON (0135-0580-02) / 184 g in 1 TUBE | 4 tube | 2023-07-01 | | No | No | Historical |