SENSODYNE PRONAMEL
- Product NDC
- 0135-0520
- 11-digit product format
- 001350520
- Labeler code
- 0135
- Product ID
- 0135-0520_0fb8d5cd-17d5-f0ac-e063-6394a90ab28d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate and sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-04-14
- 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
- Fresh Breath
- 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 |
|---|
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | | 21 |
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | | 21 |
| 0135-0520-02 | SENSODYNE PRONAMELFresh Breath | 23 g in 1 TUBE | PASTE | 23 | | 21 |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | | 21 |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 2 in 1 CARTON | PASTE | 2 | | 21 |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 77 g in 1 TUBE | PASTE | 77 | | 21 |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0520 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 7 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.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 |
|---|
| 0135-0520-01 | 00135052001 | 1 TUBE in 1 CARTON (0135-0520-01) / 113 g in 1 TUBE | 1 tube | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-02 | 00135052002 | 23 g in 1 TUBE (0135-0520-02) | 23 g | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-05 | 00135052005 | 2 TUBE in 1 CARTON (0135-0520-05) / 113 g in 1 TUBE | 2 tube | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-06 | 00135052006 | 1 TUBE in 1 CARTON (0135-0520-06) / 77 g in 1 TUBE | 1 tube | 2015-03-20 | 0000-00-00 | No | No | Current |