Sensodyne
- Product NDC
- 0135-0529
- 11-digit product format
- 001350529
- Labeler code
- 0135
- Product ID
- 0135-0529_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; 1.15 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
- Brand name suffix
- 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#
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 |
|---|---|---|---|---|---|---|
| 0135-0529-01 | SensodyneFresh Mint | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0529-01 | SensodyneFresh Mint | 23 g in 1 TUBE | PASTE | 23 | 19 | |
| 0135-0529-03 | SensodyneFresh Mint | 2 in 1 CARTON | PASTE | 2 | 19 | |
| 0135-0529-03 | SensodyneFresh Mint | 113 g in 1 TUBE | PASTE | 113 | 19 | |
| 0135-0529-04 | SensodyneFresh Mint | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0529-04 | SensodyneFresh Mint | 113 g in 1 TUBE | PASTE | 113 | 19 | |
| 0135-0529-05 | SensodyneFresh Mint | 1 in 1 CARTON | PASTE | 1 | 19 | |
| 0135-0529-05 | SensodyneFresh Mint | 77 g in 1 TUBE | PASTE | 77 | 19 | |
| 0135-0529-10 | SensodyneFresh Mint | 23 g in 1 TUBE | PASTE | 23 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0529-04 | GM - Gram | 0135-0529 | 18df28d2-9f7e-4074-b173-03447ae29209 | 1 | 2020-07-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0529 | 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, 9 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 |
|---|---|---|---|---|---|---|
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | Warnings | M022 |
| Freshness Coffee Toothpaste100g | FRESHNESS COFFEE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d79e9-2f0f-fa72-e063-6394a90a8dea | 2026-08-06 | Warnings | M022 |
| Freshness Flower Rose Toothpaste100g | FRESHNESS FLOWER ROSE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d7f5e-55e0-4fd2-e063-6294a90a92b6 | 2026-08-06 | Warnings | M022 |
| PRO-SYS | ORAL WOUND CLEANSER | Forward Science Technologies LLC | c357c8f8-6fd6-c2f8-e053-2995a90a4023 | 2026-07-30 | Warnings | M022 |
| Lornamead Natural White | FLUORIDE | Lornamead Products | 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608 | 2026-07-29 | Warnings | M022 |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | M022 |
| Good Neighbor Sore Throat Cherry Flavor | PHENOL | AMERISOURCE BERGEN | aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f | 2026-07-13 | Warnings | M022 |
| ABC Sore Throat Menthol Flavor | PHENOL | AMERISOURCE BERGEN | 9d9baf58-4790-4ff4-a462-5eb70c0e80c5 | 2026-07-13 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | P & L Development, LLC | 350b5f64-d152-40cb-b22f-98541f0e1b0a | 2026-07-09 | Warnings | M022 |
| Quality Choice Natural White | FLUORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 561a75c2-a40c-ba7c-e063-6294a90aa119 | 2026-07-08 | Warnings | M022 |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | M022 |
| Dental system starter kit | US CONVENIENCE KIT (718907) | Dyson Technology Limited | 5355b79b-711f-1a4a-e063-6394a90afc4b | 2026-06-30 | Warnings | M022 |
| Anticavity and sensitive peppermint | 907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT | Dyson Technology Limited | 5332ab71-d994-39cf-e063-6294a90a0d98 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55820ff9-7b4b-2bce-e063-6394a90a8b43 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | M022 |
| Corinz | CETYLPYRIDINIUM CHLORIDE | Sage Products, LLC | 685b6023-89c4-417e-af2d-52e831855da1 | 2026-06-29 | Warnings | M022 |
| Antiplaque solution | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | 881d4d08-4b45-486a-93af-18c0e00a5b0e | 2026-06-29 | Warnings | M022 |
| GingiCaine gel, Cherry | GINGICAINE GEL, CHERRY FLAVOR | Gingi-Pak a Division of the Belport | 6274d92e-c4e9-34fd-e053-2991aa0ae604 | 2026-06-29 | 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 |
|---|---|---|---|---|---|---|---|---|
| 0135-0529-01 | 00135052901 | 1 TUBE in 1 CARTON (0135-0529-01) / 23 g in 1 TUBE | 1 tube | 2019-01-14 | 0000-00-00 | No | No | Current |
| 0135-0529-03 | 00135052903 | 2 TUBE in 1 CARTON (0135-0529-03) / 113 g in 1 TUBE | 2 tube | 2014-12-16 | 0000-00-00 | No | No | Current |
| 0135-0529-04 | 00135052904 | 1 TUBE in 1 CARTON (0135-0529-04) / 113 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0529-05 | 00135052905 | 1 TUBE in 1 CARTON (0135-0529-05) / 77 g in 1 TUBE | 1 tube | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0135-0529-10 | 00135052910 | 23 g in 1 TUBE (0135-0529-10) | 23 g | 2023-01-02 | 0000-00-00 | No | No | Current |