SENSODYNE PRONAMEL
- Product NDC
- 0135-0484
- Requested package NDC
- 0135-0484-03
- 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 |
|---|---|---|---|---|---|---|
| Wintergreen Peppermint | POTASSIUM NITRATE, SODIUM FLUORIDE | Twice Twice LLC | 7b7beec2-e070-4102-a2a4-68c332fc9fb3 | 2026-01-19 | Warnings | M022 |
| GuruNanda Sensitive | POTASSIUM NITRATE | GURUNANDA, LLC | 3ef0d3d4-fd42-0181-e063-6394a90af09c | 2026-01-19 | Warnings | M022 |
| Up and Up Antiseptic | CETYLPYRIDINIUM CHLORIDE | Target Corporation | 386ee9f9-598e-ad00-e063-6394a90aeb46 | 2026-01-19 | Warnings | M022 |
| Colgate Sensitive Complete Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 4a8f1d2f-b326-46d2-8914-d65ccc409edf | 2026-01-18 | Warnings | M022 |
| Colgate Sensitive Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 3b656928-af58-4ee9-8fb8-360688eb9bf3 | 2026-01-13 | Warnings | M022 |
| Colgate Sensitive Enamel Health | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | a50d4259-8a79-417e-b381-72c7a8ec0418 | 2026-01-13 | Warnings | M022 |
| Walgreens Sensitive Enamel Repair | SODIUM FLUORIDE | Walgreens | 41d6384d-695b-b60b-e063-6394a90aa0b9 | 2026-01-09 | Warnings | M022 |
| HyVee Throat Drops Lemon Mint | MENTHOL | HY-VEE, INC | 47f738cc-7968-cc07-e063-6294a90af7ab | 2026-01-09 | Warnings | M022 |
| CVS Health Clinical White Stain Protector | SODIUM FLUORIDE | CVS Pharmacy | 41d5c3a9-abe5-5528-e063-6294a90ada79 | 2026-01-09 | Warnings | M022 |
| CVS Health Sensitive Enamel Repair | SODIUM FLUORIDE | CVS | 41d547b3-2feb-8e83-e063-6294a90ae3cd | 2026-01-09 | Warnings | M022 |
| Colgate Sensitive Prevent and Repair | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | e67410dc-a671-4611-8af1-097be071cd1c | 2026-01-09 | Warnings | M022 |
| Colgate Sensitive plus Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 2092c747-e025-47a9-9e54-731631d3c831 | 2026-01-09 | Warnings | M022 |
| Dentemp Canker Cover | CANKER COVER | DOC Brands | 2e7fbf9d-553c-c7bf-e063-6294a90a5f79 | 2026-01-08 | Warnings | M022 |
| HyVee Throat Drops Lemon Mint | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 47e2650f-4f50-8d85-e063-6394a90a1ddc | 2026-01-08 | Warnings | M022 |
| Dentemp Canker Cover | CANKER COVER | DOC Brands | 2b4b22e9-a03b-fb8f-e063-6394a90a8747 | 2026-01-08 | Warnings | M022 |
| Crest 3D White Advanced | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | f3aa9a59-b4d4-05d9-e053-2995a90a0aea | 2026-01-08 | M022 | |
| Oral B Plaque Defense Special Care Oral Rinse | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d503fad5-a378-0e60-e053-2a95a90abe65 | 2026-01-08 | Warnings | M022 |
| Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d5f69341-b659-c74a-e053-2a95a90a317e | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Breath Purify and Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d71ed31f-cc33-2fc3-e053-2995a90ad39b | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Clinical | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 0a295ee0-55c2-4f21-8f0a-70efc0e51694 | 2026-01-08 | 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 |
|---|---|---|---|---|---|---|---|---|
| 0135-0484-03 | 00135048403 | 22.6 g in 1 TUBE (0135-0484-03) | 22.6 g | 2010-10-18 | 0000-00-00 | No | No | Current |