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 |
|---|---|---|---|---|---|---|
| Listerine Gum Therapy Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ed6889b6-58db-41cf-e053-2a95a90a7de2 | 2024-11-11 | Warnings | M022 |
| Listerine FreshBurst Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8 | 2024-11-11 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | dd3729c2-fd05-4db0-a542-487bb0f9001f | 2024-11-11 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 9e97e4f8-80c2-44e0-862c-0dfca392a436 | 2024-11-11 | Warnings | M022 |
| Orajel 2X Medicated Gel | ORAL PAIN RELIEVER | Church & Dwight Co., Inc. | 262be295-4eaf-3136-e063-6294a90a7dcc | 2024-11-05 | Warnings | M022 |
| BIOTENE Fresh Mint Original | SODIUM FLUORIDE | Haleon US Holdings LLC | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 2024-11-05 | Warnings | M022 |
| biotene | SODIUM MONOFLUOROPHOSPHATE | Haleon US Holdings LLC | a47a6502-efb2-4072-9562-cbe293531c2b | 2024-11-04 | Warnings | M022 |
| Amosan Oral Wound Cleanser Cherry | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | a0e145c8-6b08-40be-ae4f-5678c4a78b1e | 2024-10-30 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043bfbc3-c33b-78b7-e063-6294a90a1a5a | 2024-10-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043bfbc3-c33a-78b7-e063-6294a90a1a5a | 2024-10-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043a3cb4-f560-0ffd-e063-6394a90a2ff6 | 2024-10-29 | Warnings | M022 |
| Amosan Oral Wound Cleanser Mint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | be57ca56-834f-4170-a407-f193484d8b0a | 2024-10-29 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint | SODIUM FLUORIDE | Haleon US Holdings LLC | 817c0dad-d109-428e-adb5-3354604acc94 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 1f3d68f6-afd6-42e7-b3e5-210228c8e7de | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals LLC | 0dd15227-6603-42ac-9a5f-f2dc49e0382a | 2024-10-28 | Warnings, Adverse reactions | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0605d5d6-82bd-415e-b5cb-e273f934a4a7 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic Liquid | BENZOCAINE | Beutlich Pharmaceuticals, LLC | f70fa3fc-cd65-4a80-9efd-129e98fd3998 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Menthol | PHENOL | Chain Drug Consortium | af661ef0-cdc3-4146-8ae5-59795aa49650 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Cherry Flavor | PHENOL | Chain Drug Consortium | a9cf9829-4b70-44fa-9719-240b65c06724 | 2024-10-28 | Warnings | M022 |
| Ear Wax Removal Aid Drops | CARBAMIDE PEROXIDE | PHARMACY VALUE ALLIANCE, LLC | 85ae80c1-2bc2-4c90-9559-63510d03e739 | 2024-10-28 | 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 |