SENSODYNE PRONAMEL
- Product NDC
- 0135-0520
- 11-digit product format
- 001350520
- Labeler code
- 0135
- Product ID
- 0135-0520_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
- 2011-04-14
- 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
- Fresh Breath
- 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 |
|---|---|---|---|---|---|---|
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0520-02 | SENSODYNE PRONAMELFresh Breath | 23 g in 1 TUBE | PASTE | 23 | 21 | |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 2 in 1 CARTON | PASTE | 2 | 21 | |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 77 g in 1 TUBE | PASTE | 77 | 21 | |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0520-01 | GM - Gram | 0135-0520 | c2190fd7-ded1-4129-bfa5-02973c82f4f1 | 1 | 2024-04-05 |
| 0135-0520-02 | GM - Gram | 0135-0520 | 50f8a8c0-580c-4557-97bf-559cd008aedb | 1 | 2024-04-05 |
| 0135-0520-05 | GM - Gram | 0135-0520 | 6fce3414-6b80-48bd-9898-34b66c7bff9f | 1 | 2024-04-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0520 | 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, 7 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 |
|---|---|---|---|---|---|---|
| CrystLCare Regeneration Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | GreenMark Biomedical Inc. | 4f86d0a0-d73e-5605-e063-6394a90adb38 | 2026-09-14 | Warnings | M022 |
| Opalescence Whitening Sensitivity Relief | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 44e94663-895b-67da-e063-6394a90a5fe6 | 2026-09-09 | Warnings | M022 |
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | M022 |
| Opal by Opalescence Sensitivity | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 5ffc0d14-0290-47bb-90e5-90a25a5acc28 | 2026-09-09 | Warnings | M022 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | M022 |
| SORE THROAT | PHENOL | Raritan Pharmaceuticals Inc | 43ce374a-824c-4034-bf04-c351b4d8015b | 2026-09-08 | Warnings | M022 |
| Colgate Optic White Stain Fighter Sens Relief | SODIUM FLUORIDE | Colgate-Palmolive Company | 6ec2fff7-df44-4302-be2d-97946c6cd66a | 2026-09-08 | Warnings | M022 |
| DRx Choice Sore Throat Menthol Flavor | PHENOL | RARITAN PHARMACEUTICALS INC | e3269b12-5c05-45a6-81f2-65d9f016c3aa | 2026-09-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 0733015b-e81a-4a62-82ad-dacaf3f163cb | 2026-09-02 | Warnings | M022 |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT | HEXYLRESORCINOL | Reckitt Benckiser LLC | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | M022 |
| LUDENS SUGAR FREE WILD CHERRY THROAT | PECTIN | Prestige Brands Holdings, Inc. | 274fc80c-e5b2-41c7-a119-287d6e8a2258 | 2026-08-28 | Warnings | M022 |
| Medline Peroxi Fresh Mouthwash | HYDROGEN PEROXIDE | Medline Industries, LP | ec7a9240-6c66-4471-b8b6-776e08a14fbc | 2026-08-27 | Warnings | M022 |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-08-25 | 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 |
|---|---|---|---|---|---|---|---|---|
| 0135-0520-01 | 00135052001 | 1 TUBE in 1 CARTON (0135-0520-01) / 113 g in 1 TUBE | 1 tube | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-02 | 00135052002 | 23 g in 1 TUBE (0135-0520-02) | 23 g | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-05 | 00135052005 | 2 TUBE in 1 CARTON (0135-0520-05) / 113 g in 1 TUBE | 2 tube | 2011-04-14 | 0000-00-00 | No | No | Current |
| 0135-0520-06 | 00135052006 | 1 TUBE in 1 CARTON (0135-0520-06) / 77 g in 1 TUBE | 1 tube | 2015-03-20 | 0000-00-00 | No | No | Current |