Sensodyne Pronamel
- Product NDC
- 0135-0811
- 11-digit product format
- 001350811
- Labeler code
- 0135
- Product ID
- 0135-0811_4124888c-4bab-f7b5-e063-6394a90a7532
- 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
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
- Clinical Enamel Strength Whitening Action
- 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 |
|---|---|
| e8a62f24-1db6-45fb-b6e1-5e57103f82bc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0811-02 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 96.4 g in 1 TUBE | PASTE | 96.4 | 2 | |
| 0135-0811-02 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0811-03 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0811-03 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 65.2 g in 1 TUBE | PASTE | 65.2 | 2 | |
| 0135-0811-23 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 96.4 g in 1 TUBE | PASTE | 96.4 | 2 | |
| 0135-0811-23 | Sensodyne PronamelClinical Enamel Strength Whitening Action | 2 in 1 CARTON | PASTE | 2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0811 | SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH WHITENING ACTION (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 1 | Current NDC, 6 package rows | 20250107_e8a62f24-1db6-45fb-b6e1-5e57103f82bc.zip |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Crest Pro-Health Breath Purify and Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d71ed31f-cc33-2fc3-e053-2995a90ad39b | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Clinical | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 0a295ee0-55c2-4f21-8f0a-70efc0e51694 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d721e2cb-8f67-3d07-e053-2995a90ae65a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advantage | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | ddcd56fe-25d6-8195-e053-2a95a90a575a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dc1f31-625d-a032-e053-2995a90a730d | 2026-01-08 | Warnings | M022 |
| Crest Pro Health Gum plus Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c598a4ab-5981-0068-e053-2a95a90af4fa | 2026-01-08 | Warnings | M022 |
| Oral B Gum Detoxify Special Care Rinse | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dcdde4-5542-1f87-e053-2995a90a261c | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Fresh Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 62991165-ec81-48a8-e053-2991aa0a54f3 | 2026-01-08 | Warnings | M022 |
| Crest Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 72f1a02f-1d02-7e83-e053-2a91aa0a7947 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 6287bc3e-8b05-45d3-e053-2991aa0aaa10 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Multi-Protection Refreshing Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 8867d791-7e93-4f39-aaaf-bfbee8296fd9 | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | HEB | a71c5259-cbcf-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| Topco Associates LLC Maximum Strength | FLUORIDE | Topco Associates LLC | 387d264c-90cc-5e67-e063-6394a90a713d | 2026-01-08 | Warnings | M022 |
| TopCare Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | TOPCO Assoc. LLC | 835f41cf-e920-7df7-e053-2a91aa0a4479 | 2026-01-08 | Warnings | M022 |
| Scope Icy Blast | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 164ed151-01d3-021a-e063-6294a90a0e51 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advanced Enamel Care | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1660e7d7-5b8d-8aba-e063-6294a90a50d8 | 2026-01-08 | Warnings | M022 |
| Crest Deep Cleanse Germ Treatment | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 2d6b15d4-7827-ec2f-e063-6294a90a82c8 | 2026-01-08 | Warnings | M022 |
| Crest Scope Original | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 21eed451-9368-146c-e063-6294a90af62b | 2026-01-08 | Warnings | M022 |
| 3x Medicated Mouth Sore Gel | BENZOCAINE | HEB | a71c5259-cbd1-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| HEB Extra Whitening | FLUORIDE | HEB | b76c3591-6383-4661-b3db-7a56b11202f7 | 2026-01-08 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | e8a62f24-1db6-45fb-b6e1-5e57103f82bc | 2 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | e8a62f24-1db6-45fb-b6e1-5e57103f82bc | 2 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | e8a62f24-1db6-45fb-b6e1-5e57103f82bc | 2 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | e8a62f24-1db6-45fb-b6e1-5e57103f82bc | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0135-0811-02 | 00135081102 | 1 TUBE in 1 CARTON (0135-0811-02) / 96.4 g in 1 TUBE | 1 tube | 2025-01-06 | No | No | Current |
| 0135-0811-03 | 00135081103 | 1 TUBE in 1 CARTON (0135-0811-03) / 65.2 g in 1 TUBE | 1 tube | 2025-01-06 | No | No | Current |
| 0135-0811-23 | 00135081123 | 2 TUBE in 1 CARTON (0135-0811-23) / 96.4 g in 1 TUBE | 2 tube | 2025-12-01 | No | No | Current |