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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 872365ca-0c6b-550a-e053-2a91aa0ab25a | 2024-06-14 | Warnings | M022 |
| Amosan Oral Wound Cleanser Spearmint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | 7ac6c649-758f-4128-9920-466c0967b86a | 2024-05-21 | Warnings | M022 |
| Sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 2024-05-15 | Warnings | M022 |
| Sensodyne Extra Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 2024-05-15 | Warnings | M022 |
| Attitude Adult Fluoride-free - Sensitive - Spearmint | POTASSIUM NITRATE | 9055-7588 Qubec Inc. DBA Attitude | 46d5c908-f0e3-444c-9d96-461feef39137 | 2024-05-14 | Warnings | M022 |
| sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 16225f06-1d40-416a-aaec-7890e398fe4b | 2024-05-13 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | QUALITY CHOICE (Chain Drug Marketing Association) | 9162ae27-ddbb-4336-9655-487995919de4 | 2024-05-01 | Warnings | M022 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE AND POTASSIUM NITRATE | 9055-7588 Quebec Inc. DBA Attitude | 42b79ec5-f37f-4dc9-9631-c8b1c153fe88 | 2024-04-26 | Warnings | M022 |
| Quality Choice Oral Pain Relief | BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1% | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 162702b4-4bf7-8868-e063-6294a90a5921 | 2024-04-15 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 9991de96-99a1-42f0-9ddd-e530ca9ceab1 | 2024-04-11 | Warnings | M022 |
| Aquafresh Extreme Clean Pure Breath Action | SODIUM FLUORIDE | Haleon US Holdings LLC | 462eb309-deca-4464-b13a-7ae314e53ede | 2024-04-08 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | Family Dollar (FAMILY WELLNESS) | 7806fac7-736e-44b0-baa2-42feb7237417 | 2024-03-27 | Warnings | M022 |
| Sucrets | DYCLONINE HCL, MENTHOL, AND PECTIN | Insight Pharmaceuticals LLC | 2a2839ea-11d3-4390-930d-0da912a9c6f5 | 2024-03-20 | Warnings | M022 |
| Sucrets Sore Throat Wild Cherry | DYCLONINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | da4967c7-ee18-42e7-8c97-8919f3bb1b7d | 2024-03-20 | Warnings | M022 |
| NATEAN Clean plus Sensitivity Relief | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cea6f992-8a44-4eb8-baea-97b7b181b227 | 2024-03-19 | Warnings | M022 |
| NATEAN Clean and Whiten | SODIUM FLUORIDE | Haleon US Holdings LLC | 71b95962-2693-49f5-94d2-f2a035b5e0c8 | 2024-03-19 | Warnings | M022 |
| SENSODYNE Sensitivity and Gum Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | ed093acd-255c-40ff-a010-d276f5844453 | 2024-03-07 | Warnings | M022 |
| SENSODYNE Sensitivity Gum and Enamel Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2 | 2024-03-07 | Warnings | M022 |
| Sensodyne True white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 671f8f45-389c-4375-be43-f5500ee21a0e | 2024-03-07 | Warnings | M022 |
| Sensodyne Pronamel Strong and Bright Enamel Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | be1ae382-0e01-4db8-90d7-fdadec2ff861 | 2024-03-06 | 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 |