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 |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | 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 |