Sensodyne Pronamel
- Product NDC
- 0135-0644
- Requested package NDC
- 0135-0644-01
- 11-digit product format
- 001350644
- Labeler code
- 0135
- Product ID
- 0135-0644_12de1c78-243f-d69b-e063-6394a90ae450
- 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
- 2023-04-03
- 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sensodyne Pronamel
- Brand name suffix
- Gentle Whitening Fresh Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1.15 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RU45X2JN0Z | Internal UNII lookup |
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1086243 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0644-01 | Sensodyne PronamelGentle Whitening Fresh Mint | 113 g in 1 TUBE | PASTE | 113 | 2 | |
| 0135-0644-01 | Sensodyne PronamelGentle Whitening Fresh Mint | 1 in 1 CARTON | PASTE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0135-0644-01 | 00135064401 | 1 TUBE in 1 CARTON (0135-0644-01) / 113 g in 1 TUBE | 1 tube | 2023-04-03 | No | No | Current |