SENSODYNE PRONAMEL
- Product NDC
- 0135-0484
- 11-digit product format
- 001350484
- Labeler code
- 0135
- Product ID
- 0135-0484_0fb8d5cd-17d5-f0ac-e063-6394a90ab28d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate and sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-10-18
- 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 PRONAMEL
- Brand name suffix
- Gentle Whitening
- 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#
| Identifier | FDA.report destination |
|---|---|
| 1086243 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| edffce4d-108b-4ffd-9adf-e12cb42ffddd | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0484-01 | SENSODYNE PRONAMELGentle Whitening | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0484-01 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-02 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-02 | SENSODYNE PRONAMELGentle Whitening | 76.5 g in 1 TUBE | PASTE | 76.5 | 21 | |
| 0135-0484-03 | SENSODYNE PRONAMELGentle Whitening | 22.6 g in 1 TUBE | PASTE | 22.6 | 21 | |
| 0135-0484-04 | SENSODYNE PRONAMELGentle Whitening | 184.3 g in 1 TUBE | PASTE | 184.3 | 21 | |
| 0135-0484-04 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-05 | SENSODYNE PRONAMELGentle Whitening | 2 in 1 CARTON | PASTE | 2 | 21 | |
| 0135-0484-05 | SENSODYNE PRONAMELGentle Whitening | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0484-06 | SENSODYNE PRONAMELGentle Whitening | 4 in 1 CARTON | PASTE | 4 | 21 | |
| 0135-0484-06 | SENSODYNE PRONAMELGentle Whitening | 184.3 g in 1 TUBE | PASTE | 184.3 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0484-02 | GM - Gram | 0135-0484 | 66d6ea4d-2c37-4d94-86ec-bf5e3493d44a | 1 | 2025-09-12 |
| 0135-0484-03 | GM - Gram | 0135-0484 | 724e25a8-6f21-4997-af71-c3dcc76b0fca | 1 | 2024-09-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0484 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 11 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.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 |
|---|---|---|---|---|---|---|
| Patterson Dental Topical Anesthetic | BENZOCAINE | Patterson Dental | 72fd2232-cd5a-4e25-b139-522b589c4472 | 2025-01-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 42521b29-67e4-4a16-848d-7e6ba4a7ece2 | 2025-01-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals LLC | 723da3ae-3f1f-4962-920b-f2a30c8c3253 | 2025-01-08 | Warnings, Adverse reactions | M022 |
| V34 Colour Corrector | V34 COLOUR CORRECTOR | Jiangxi Dentalbright Technology Co., Ltd | 2b2a0b47-7628-4b85-e063-6294a90a45a0 | 2025-01-07 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | fb38b10d-0faf-403c-9921-d4f6b0f6aa55 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | a9dc2245-c029-4453-bfc5-8fb899873c34 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | ba49a18d-8568-421b-a495-8fee863c9757 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | c9b584d9-7407-445a-b084-926250af9f8e | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 4aa6eec8-394a-4ecb-8173-66561fd64913 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 25c99ae3-90f4-4a63-924d-f810b3ba6e60 | 2025-01-03 | Warnings | M022 |
| Benzo-Jel | BENZOCAINE | Henry Schein Inc. | 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 | 2025-01-03 | Warnings | M022 |
| Prevention Oncology Mouth Rinse | GLYCERIN | Prevention Health Sciences, Inc. | 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c | 2025-01-01 | Warnings | M022 |
| Prevention Mouth Sore Rinse | HYDROGEN PEROXIDE | Prevention Health Sciences, Inc. | 2eae61e4-1800-5fa6-e063-6394a90a9583 | 2025-01-01 | Warnings | M022 |
| Antiseptic Lil Drug Store Products | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Lil' Drug Store Products, Inc | dca36a30-2c9f-4d0b-be88-b45c7046f509 | 2024-12-31 | Warnings | M022 |
| Sensodyne Clinical White Intensive Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | f193ec40-032f-42c7-81f1-029ec8989374 | 2024-12-31 | Warnings | M022 |
| TeethWhitening Kit | TEETHWHITENING KIT | Jiangxi Dentalbright Technology Co., Ltd. | 29393313-217a-dc3a-e063-6294a90addb1 | 2024-12-20 | Warnings | M022 |
| Breezers Cool Berry | PECTIN | Mondelez Global LLC | b31d0078-21d7-4d18-a8d3-7c8d48d6d004 | 2024-12-20 | Warnings | M022 |
| Breezers Creamy Strawberry | PECTIN | Mondelez Global LLC | 777fd6db-f129-4489-8312-4b1aca94878e | 2024-12-20 | Warnings | M022 |
| Halls Breezers Sugar Free Cool Berry | PECTIN | Mondelez Global LLC | dd1b4b17-4f73-4052-9589-d5fd6bb059bb | 2024-12-20 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 21 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 21 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 21 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0484-01 | 00135048401 | 1 TUBE in 1 CARTON (0135-0484-01) / 113 g in 1 TUBE | 1 tube | 2010-10-18 | 0000-00-00 | No | No | Current |
| 0135-0484-02 | 00135048402 | 1 TUBE in 1 CARTON (0135-0484-02) / 76.5 g in 1 TUBE | 1 tube | 2010-10-18 | 0000-00-00 | No | No | Current |
| 0135-0484-03 | 00135048403 | 22.6 g in 1 TUBE (0135-0484-03) | 22.6 g | 2010-10-18 | 0000-00-00 | No | No | Current |
| 0135-0484-04 | 00135048404 | 1 TUBE in 1 CARTON (0135-0484-04) / 184.3 g in 1 TUBE | 1 tube | 2019-07-01 | 0000-00-00 | No | No | Current |
| 0135-0484-05 | 00135048405 | 2 TUBE in 1 CARTON (0135-0484-05) / 113 g in 1 TUBE | 2 tube | 2010-10-18 | 0000-00-00 | No | No | Current |
| 0135-0484-06 | 00135048406 | 4 TUBE in 1 CARTON (0135-0484-06) / 184.3 g in 1 TUBE | 4 tube | 2014-12-16 | 0000-00-00 | No | No | Current |