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 |
|---|---|---|---|---|---|---|
| Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry | FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 3573f149-2af9-4c86-e063-6294a90a7b3f | 2025-05-18 | Warnings | M022 |
| Bubble Gum Flavor For Kids 25g 50g | BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 354c1eda-ec5b-a8c7-e063-6294a90a871d | 2025-05-16 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Safeway, Inc. | 8fe2f1df-3264-455d-b62c-953dce171c02 | 2025-05-16 | Warnings | M022 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshener | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 32b632bf-058d-447b-a7fb-a9dd05c1e2b8 | 2025-05-08 | Warnings | M022 |
| Parodontax Active Gum Health Clear Mint | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 | 2025-05-08 | Warnings | M022 |
| Listerine Clinical Solutions Gum Health Icy Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 06e1122b-1100-43c0-e063-6394a90a2e78 | 2025-04-22 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Strategic Sourcing Services LLC | 5260258a-bb1e-43d6-bce1-70a38778a64a | 2025-04-14 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | TARGET Corporation | 93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65 | 2025-04-14 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee467ec4-bd5e-644a-e053-2a95a90ac273 | 2025-04-10 | Warnings | M022 |
| Mouthwash | MENTHOL, METHYL SALICYLATE, THYMOL | Orazen Inc | 873c43df-1d46-359b-e053-2a91aa0a4319 | 2025-04-07 | Warnings | M022 |
| Sensodyne Complete Protection Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | e3cc3146-8aed-4f6b-a252-e379418c2b8d | 2025-03-26 | Warnings | M022 |
| Listerine Freshburst Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee1e1df9-74c6-d24b-e053-2a95a90a43d3 | 2025-03-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | edb9e374-4dba-5823-e053-2a95a90a3da5 | 2025-03-03 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Good Sense (Geiss, Destin & Dunn, Inc.) | cfe9be26-e4a4-413c-a602-2f5948e3bb7a | 2025-03-03 | Warnings | M022 |
| LISTERINE Original Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 78e2e172-09a4-4bf1-9871-d099c49087be | 2025-02-28 | Warnings | M022 |
| WHITE GLO CHARCOAL SENSITIVE | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | a5edb7fd-c637-5447-e053-2995a90a5a6f | 2025-02-26 | Warnings | M022 |
| Glorysmile Toothpaste. | GLORYSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 2ef48156-904d-e42a-e063-6394a90a3cd0 | 2025-02-25 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Walgreens | c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa | 2025-02-21 | Warnings | M022 |
| Sheffield Pain Relief | BENZOCAINE | Sheffield Pharmaceuticals LLC | e21abfdd-373d-42af-9535-fe1571382a65 | 2025-02-19 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Whole Foods Market | a2bb142e-8cbe-481e-bf4f-810ca6d14591 | 2025-02-12 | 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 |