Sensodyne Pronamel
- Product NDC
- 0135-0809
- 11-digit product format
- 001350809
- Labeler code
- 0135
- Product ID
- 0135-0809_395866d4-ad69-4f60-8c4c-1c910aba1c38
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-06
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.1 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
- Kids Berry Twist
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 69c07c36-b5e0-420b-ab29-7d1091386322 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0809-01 | Sensodyne PronamelKids Berry Twist | 1 in 1 CARTON | PASTE | 1 | 2 | |
| 0135-0809-01 | Sensodyne PronamelKids Berry Twist | 113 g in 1 TUBE | PASTE | 113 | 2 | |
| 0135-0809-02 | Sensodyne PronamelKids Berry Twist | 23 g in 1 TUBE | PASTE | 23 | 2 | |
| 0135-0809-03 | Sensodyne PronamelKids Berry Twist | 113 g in 1 TUBE | PASTE | 113 | 2 | |
| 0135-0809-03 | Sensodyne PronamelKids Berry Twist | 2 in 1 CARTON | PASTE | 2 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Quality Choice Maximum Strength Oral Pain Relieving | BENZOCAINE | Chain Drug Marketing Association Inc | dbde8e7f-85d8-4083-b01a-3a7e410a7747 | 2025-10-17 | Warnings | M022 |
| Quality Choice | BENZOCAINE | Chain Drug Marketing Association, Inc. | 24c3c4a3-bd76-198d-e063-6394a90ad45a | 2025-10-16 | Warnings | M022 |
| Sore Throat Relief Cherry Flavor | PHENOL | Cardinal Health | b84203bd-23e9-427d-83d8-f4c88266e23c | 2025-10-14 | Warnings | M022 |
| Finafta | BENZOCAINE, GLYCERIN | Efficient Laboratories Inc. | 03368603-3e11-c2fa-e063-6294a90a04ea | 2025-10-14 | Warnings | M022 |
| Sensodyne Pronamel Clinical Enamel Strength Whitening Action | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | e8a62f24-1db6-45fb-b6e1-5e57103f82bc | 2025-10-14 | Warnings | M022 |
| evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Ashtel Studios, Inc. | bc74d2a6-fe34-44cf-b015-70ed4d47c933 | 2025-10-13 | Warnings | M022 |
| Listerine Essential Care | SODIUM MONOFLUOROPHOSPHATE | Kenvue Brands LLC | 90b5c3d8-baa4-44ab-8f73-e177007f0219 | 2025-10-10 | Warnings | M022 |
| Anesgerm LA MUELA Fast Pain Relief | BENZOCAINE 20% | Germa Products, LLC | bf7842a2-9c0b-3fc3-e053-2995a90a36c1 | 2025-10-10 | Warnings | M022 |
| Aftaseptic Instant Pain Relief | SALISYLIC ACID 1% | Germa Products, LLC | beb32fba-503a-f5e5-e053-2a95a90a57e5 | 2025-10-10 | Warnings | M022 |
| DuoCare Clinical Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Medline Industries, LP | 98e61cd5-7e29-7066-e053-2a95a90afa21 | 2025-10-10 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 40b756b7-ce1b-6482-e063-6294a90a0425 | 2025-10-09 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Gil Pharmaceutical Corp | 85053391-8d71-ab4f-e053-2991aa0a7e08 | 2025-10-09 | Warnings | M022 |
| Listerine Gum Therapy Mouthwash Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 40a0bdf3-1698-1449-e063-6394a90ab13d | 2025-10-08 | Warnings | M022 |
| Kalaya Breath Refresh | MOUTHWASH | Avaria Health and Beauty Corp | 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0 | 2025-10-08 | Warnings | M022 |
| Trader Joes | SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5% | TRADER JOE'S COMPANY | 159abeba-6da2-2643-e063-6394a90a730d | 2025-10-08 | Warnings | M022 |
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | M022 |
| Vicks VapoCool Sore Throat | BENZOCAINE AND MENTHOL | The Procter & Gamble Manufacturing Company | 8749824b-6d04-430d-e053-2995a90a2db8 | 2025-10-06 | Warnings | M022 |
| Vicks VapoCool SEVERE | MENTHOL | The Procter & Gamble Manufacturing Company | c77f8878-5eef-b006-e053-2a95a90a1866 | 2025-10-03 | Warnings | M022 |
| Vicks VapoCOOL SEVERE | MENTHOL | The Procter & Gamble Manufacturing Company | 042b6ea0-baf3-52d2-e063-6394a90ac6fb | 2025-10-03 | Warnings | M022 |
| Equate Glistening Mint | SODIUM FLUORIDE | Walmart Inc. | 39ff21ee-a362-014e-e063-6294a90a0d91 | 2025-10-03 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0135-0809-01 | 00135080901 | 1 TUBE in 1 CARTON (0135-0809-01) / 113 g in 1 TUBE | 1 tube | 2025-01-06 | No | No | Current |
| 0135-0809-02 | 00135080902 | 23 g in 1 TUBE (0135-0809-02) | 23 g | 2025-01-06 | No | No | Current |
| 0135-0809-03 | 00135080903 | 2 TUBE in 1 CARTON (0135-0809-03) / 113 g in 1 TUBE | 2 tube | 2026-01-01 | No | No | Current |