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 |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
| RU45X2JN0Z | 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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb2 | 2025-12-17 | Warnings | M022 |
| Sore Throat | PHENOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 9128d59c-6fa9-4358-865a-802257a9bd25 | 2025-12-16 | Warnings | M022 |
| S.T.37 | HEXYLRESORCINOL | NUMARK BRANDS, INC | 7d7acca2-aa8a-5272-e813-faab039cc798 | 2025-12-15 | Warnings | M022 |
| Esunix Oral Bacteriostatic Gel | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999851ac-925c-7d1f-e053-2a95a90a240b | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For Toothache and Gum | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99a2b061-0875-59a4-e053-2995a90ab373 | 2025-12-12 | Warnings | M022 |
| Orajel Antiseptic Rinse For All Mouth Sores | HYDROGEN PEROXIDE AND MENTHOL | Church & Dwight Co., Inc. | 06188d36-0d60-6ae6-e054-00144ff8d46c | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For All Mouth Sores | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99b589ac-9833-fb60-e053-2995a90a0935 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum, Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999aa7b9-bf9e-9285-e053-2a95a90a345b | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated PM For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999cff2b-c23e-5abe-e053-2a95a90a7569 | 2025-12-12 | Warnings | M022 |
| Vicks Formula 44 Cough Drops | MENTHOL | The Procter & Gamble Manufacturing Company | bb9e483e-095d-8a42-e053-2a95a90ad8d6 | 2025-12-12 | Warnings | M022 |
| Benzoin Compound Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | a893a232-2ea8-4e0d-8cbf-7f5040b3be2e | 2025-12-11 | Warnings | M022 |
| Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 456d45e8-bf6d-31c4-e063-6394a90a5c00 | 2025-12-10 | Warnings | M022 |
| Oral pain relief | BENZOCAINE | ALAINA HEALTHCARE PRIVATE LIMITED | d98c1b2f-fe75-4d52-b082-1abb7628c59e | 2025-12-09 | Warnings | M022 |
| HEB Sensitive Extra Whitening Twin | SODIUM FLUORIDE | HEB | 41d5ae3e-51c1-263b-e063-6394a90a3312 | 2025-12-08 | Warnings | M022 |
| CankerMelts | BENZOCAINE | Quest Products, LLC | 070dae82-14c2-66d2-e063-6394a90ab259 | 2025-12-04 | Warnings | M022 |
| Sore Throat ReadyInCase | PHENOL | P & L Development, LLC | 2fb3d17e-8ca3-4edb-8b82-4b484f42616e | 2025-12-03 | Warnings | M022 |
| Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 44f2b66a-26ae-1044-e063-6394a90a9ab6 | 2025-12-02 | Warnings | M022 |
| Sensodyne Fresh Clean | STANNOUS FLUORIDE | Haleon US Holdings LLC | 2d433ac1-3ddf-a2f4-e063-6394a90a91f8 | 2025-12-01 | Warnings | M022 |
| Walgreens Saline | NASAL | WALGREEN COMPANY | 147e45c8-1e71-4c06-89f1-42e9f9683366 | 2025-12-01 | 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 |