Sensodyne
- Product NDC
- 0135-0525
- 11-digit product format
- 001350525
- Labeler code
- 0135
- Product ID
- 0135-0525_18835f57-a509-2ac6-e063-6394a90a8aaf
- 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
- 1990-09-30
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 50; 1.11 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
- Brand name suffix
- Extra Whitening
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1.11 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
| RU45X2JN0Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ed4a62b-f1d3-4740-8150-b94e02398740 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0525-03 | SensodyneExtra Whitening | 2 in 1 CARTON | PASTE | 2 | 19 | |
| 0135-0525-03 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-04 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-04 | SensodyneExtra Whitening | 113 g in 1 TUBE | PASTE | 113 | 19 | |
| 0135-0525-05 | SensodyneExtra Whitening | 77 g in 1 TUBE | PASTE | 77 | 19 | |
| 0135-0525-05 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-06 | SensodyneExtra Whitening | 170 g in 1 TUBE | PASTE | 170 | 19 | |
| 0135-0525-06 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-07 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-07 | SensodyneExtra Whitening | 23 g in 1 TUBE | PASTE | 23 | 19 | |
| 0135-0525-08 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-08 | SensodyneExtra Whitening | 184 g in 1 TUBE | PASTE | 184 | 19 | |
| 0135-0525-11 | SensodyneExtra Whitening | 3 in 1 CARTON | PASTE | 3 | 19 | |
| 0135-0525-11 | SensodyneExtra Whitening | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0525-13 | SensodyneExtra Whitening | 184 g in 1 TUBE | PASTE | 184 | 19 | |
| 0135-0525-13 | SensodyneExtra Whitening | 4 in 1 CARTON | PASTE | 4 | 19 | |
| 0135-0525-14 | SensodyneExtra Whitening | 184 g in 1 TUBE | PASTE | 184 | 19 | |
| 0135-0525-14 | SensodyneExtra Whitening | 4 in 1 CARTON | PASTE | 4 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0525-04 | GM - Gram | 0135-0525 | 89cce668-42f0-4c51-8e01-45964bb0b86e | 1 | 2024-04-05 |
| 0135-0525-07 | GM - Gram | 0135-0525 | c1123b61-68e2-415a-a612-f1c720ac7bcb | 1 | 2024-09-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0525 | SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 19 | Current NDC, Legacy NDC, 18 package rows | 20240517_1ed4a62b-f1d3-4740-8150-b94e02398740.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 |
|---|---|---|---|---|---|---|
| Sensitivity Relief Fluoride Free | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | c23b2a83-ebc3-4bcf-a216-7693944dcfa0 | 2026-05-22 | Warnings | M022 |
| Sensitivity and Gum with Cavity Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Health and Natural Beauty USA Corp | 137d6935-19a3-499d-957c-820156eec7a5 | 2026-05-22 | Warnings | M022 |
| SEXYTEETH MINTY T00THPASTE | SEXYTEETH MINTY TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51d288c1-fe86-ffe1-e063-6394a90ab4c4 | 2026-05-14 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat cherry | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 2026-05-12 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat honey lemon | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | d771095b-7de3-48f3-a125-8bc76e7d1778 | 2026-05-12 | Warnings | M022 |
| SEXYTEETH CHARCOAL T00THPASTE | SEXYTEETH CHARCOAL TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51ab8a9a-6c12-b13b-e063-6294a90ace2a | 2026-05-12 | Warnings | M022 |
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity | FLUORIDE | WHOLE FOODS | 25bc7ab1-116d-143a-e063-6394a90aa970 | 2026-05-04 | Warnings | M022 |
| Gingicaine Gel Strawberry | GINGICAINE GEL STRAWBERRY FLAVOR | Gingi-Pak a Division of the Belport | 2fd37612-a28b-3aa1-e054-00144ff8d46c | 2026-05-01 | Warnings | M022 |
| 3ECARE Dual formula WhiteningToothpaste Refill | SODIUM FLUORIDE | Hangzhou Namei Zhikang Technology Co., Ltd. | 501df1c7-4884-bb39-e063-6294a90aaf6a | 2026-04-23 | Warnings | M022 |
| Ora YoGu 4X Medicated Tooth and Gum Pain Reliever | MEDICATED TOOTH AND GUM PAIN RELIEVER | Kungpo Health Care & Herbal Center Inc | 1f10a72f-0b49-41cb-92f9-b0160d7664de | 2026-04-22 | Warnings | M022 |
| EverSmile AlignerFresh Enamel Guard | SODIUM FLUORIDE | Everbrands, Inc. | 7b3d0114-dac0-4370-8545-922ec018018e | 2026-04-21 | Warnings | M022 |
| PREOP | HYDROGEN PEROXIDE | Everbrands, Inc. | cc5cdd29-92c1-4ce0-997e-eb624b288b09 | 2026-04-20 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | CVS | a7576238-e7c8-7e86-e053-2995a90aaeb5 | 2026-04-20 | Warnings | M022 |
| CVS Pharmacy Maximum Strength | BENZOCAINE | CVS Pharmacy | 92747826-cf58-4406-b3b5-12f7c7077c2c | 2026-04-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | 9f991292-bbaa-4f4e-b2cb-059d1a04849e | 2026-04-20 | Warnings | M022 |
| Osstem S Sensitivity relief tooth | POTASSIUM NITRATE, SODIUM FLUORIDE | Osstem Pharma Co., Ltd | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 2026-04-15 | Warnings | M022 |
| Crest Pro-Health Gum DetoxifyWinter Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6db58f-0b09-d155-e063-6394a90ae658 | 2026-04-14 | Warnings | M022 |
| Lolleez Orange Mango | PECTIN | BFY LLC | 4f6dec8b-078a-f321-e063-6294a90a248c | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Gum Restore Smooth Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6e3b36-e565-7d27-e063-6294a90ae5ac | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Nightly Bacteria Shield | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6ec1e0-c6b5-226f-e063-6294a90a8f14 | 2026-04-14 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1038841 | potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste | PSN | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038841 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste | SCD | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038841 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038841 | pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038841 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038841 | potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0525-03 | 00135052503 | 2 CARTON in 1 CARTON (0135-0525-03) / 1 TUBE in 1 CARTON / 113 g in 1 TUBE | 2 carton | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-04 | 00135052504 | 1 TUBE in 1 CARTON (0135-0525-04) / 113 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-05 | 00135052505 | 1 TUBE in 1 CARTON (0135-0525-05) / 77 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-06 | 00135052506 | 1 TUBE in 1 CARTON (0135-0525-06) / 170 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-07 | 00135052507 | 1 TUBE in 1 CARTON (0135-0525-07) / 23 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-08 | 00135052508 | 1 TUBE in 1 CARTON (0135-0525-08) / 184 g in 1 TUBE | 1 tube | 2019-07-01 | 0000-00-00 | No | No | Current |
| 0135-0525-11 | 00135052511 | 3 CARTON in 1 CARTON (0135-0525-11) / 1 TUBE in 1 CARTON / 184 g in 1 TUBE | 3 carton | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0525-13 | 00135052513 | 4 TUBE in 1 CARTON (0135-0525-13) / 184 g in 1 TUBE | 4 tube | 2016-06-23 | 0000-00-00 | No | No | Current |
| 0135-0525-14 | 00135052514 | 4 TUBE in 1 CARTON (0135-0525-14) / 184 g in 1 TUBE | 4 tube | 2023-07-01 | No | No | Current |