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 |
|---|---|
| RU45X2JN0Z | Internal UNII lookup |
| 8ZYQ1474W7 | 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 |
|---|---|---|---|---|---|---|
| Oral Gel Oral Pain Relief | BENZOCAINE BENZALKONIUM CHLORIDE | Savvy Care and Cosmetics | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2024-12-19 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint | SODIUM BICARBONATE | Lotus Brands, Inc. | 4a95c8c1-db7c-4791-ac58-3eac216a0126 | 2024-12-18 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon | SODIUM BICARBONATE | Lotus Brands, Inc. | 6703b29d-cdc9-4c74-91c0-fb0c98dd043e | 2024-12-18 | Warnings | M022 |
| Red Cross Oral Pain Relief | BENZOCAINE | The Mentholatum Company | cbd41429-f730-4577-9f06-ef1831cf62e1 | 2024-12-17 | Warnings | M022 |
| Red Cross Canker Sore | BENZOCAINE | The Mentholatum Company | 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 | 2024-12-17 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | 116956644 | 2981217f-f250-c090-e063-6294a90a85b0 | 2024-12-17 | Warnings | M022 |
| Kank-A Mouth Pain | BENZOCAINE | Blistex Inc. | eebc03ba-f849-4e70-a653-834f383b6aa4 | 2024-12-17 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8282a4a6-b77c-75fc-e053-2991aa0ad4ac | 2024-12-16 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | 9452bff4-8c08-eff9-e053-2a95a90a67ed | 2024-12-16 | Warnings | M022 |
| PHENOL | PHENOL | CHAIN DRUG MARKETING ASSOCIATION INC. | 2379e23a-72fe-4e94-9d7e-9b623c0db174 | 2024-12-13 | Warnings | M022 |
| KANKA SoftBrush | BENZOCAINE AND ZINC CHLORIDE | Blistex Inc | 093f3545-1d8e-48a3-a533-e9c3ae6d740b | 2024-12-12 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 826eaef8-4457-3dc2-e053-2991aa0a528b | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories, Inc. | e3d924b5-0788-46d3-e053-2995a90a027b | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | fa433031-7376-0e5b-e053-6394a90a5f75 | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | eedf13dc-a009-027a-e053-2995a90a8ec8 | 2024-12-11 | Warnings | M022 |
| NATURAL LEMON MINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | 763e8234-60be-4b1f-9f78-01c574f35d0a | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | 989f8509-cd28-48e7-9aa1-baddfbcac95a | 2024-12-10 | 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 |