SENSODYNE
- Product NDC
- 0135-0548
- 11-digit product format
- 001350548
- Labeler code
- 0135
- Product ID
- 0135-0548_1309c3eb-8c5c-c532-e063-6394a90a5529
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- stannous fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-06-28
- Substance
- STANNOUS 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
- Brand name suffix
- Repair and Protect
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416784 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34260c69-d829-46c0-b12a-5136ee073ba1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0548-01 | SENSODYNERepair and Protect | 23 g in 1 TUBE | PASTE | 23 | 13 | |
| 0135-0548-01 | SENSODYNERepair and Protect | 1 in 1 CARTON | PASTE | 1 | 13 | |
| 0135-0548-02 | SENSODYNERepair and Protect | 96.4 g in 1 TUBE | PASTE | 96.4 | 13 | |
| 0135-0548-02 | SENSODYNERepair and Protect | 1 in 1 CARTON | PASTE | 1 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0548 | SENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 13 | Current NDC, Legacy NDC, 4 package rows | 20240308_34260c69-d829-46c0-b12a-5136ee073ba1.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 |
|---|---|---|---|---|---|---|
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | fc86b98e-d556-4769-e053-6394a90afc6e | 2026-01-08 | Warnings | M022 |
| Care One Maximum Strength | FLUORIDE | American Sales | 1b6618ea-6533-41d7-be2c-13bb9e108dc5 | 2026-01-08 | Warnings | M022 |
| equate Sensitive | POTASSIUM NITRATE, SODIUM FLUORIDE | Wal-Mart Stores Inc | 79899b59-3a16-6504-e053-2991aa0a895a | 2026-01-08 | Warnings | M022 |
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | 451283d3-78b0-8361-e063-6294a90a1fd5 | 2026-01-08 | Warnings | M022 |
| CVS Maximum Strength | BENZOCAINE | CVS Pharmacy | 8691d6b6-741e-47b2-8332-76742b34715f | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Gel | BENZOCAINE | Publix Super Markets INC | 16eb9d15-dba3-36e6-e063-6394a90ab859 | 2026-01-08 | Warnings | M022 |
| Toothache and Gum Relief | BENZOCAINE, MENTHOL | CVS Pharmacy | 814ec7bf-f825-1095-e053-2a91aa0aee59 | 2026-01-08 | Warnings | M022 |
| Lemon | GLYCERIN | Sion Biotext Medical Ltd | dbd7ed86-1b92-4471-827a-89f3afa1b0dc | 2026-01-08 | Warnings | M022 |
| Sootheez Organic Wild Cherry | PECTIN | BFY LLC | 47baa2a8-270c-fa07-e063-6394a90a97f6 | 2026-01-06 | Warnings | M022 |
| Parodontax Gum Strengthen and Protect | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 3bb378c8-14b2-aa13-e063-6294a90a4db3 | 2026-01-05 | Warnings | M022 |
| MySweetSmile Toothpaste. | MYSWEETSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478baf87-9276-7288-e063-6294a90a9e8e | 2026-01-04 | Warnings | M022 |
| MySweetSmile Mango Toothpaste. | MYSWEETSMILE MANGO TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478cbdeb-28e1-fa56-e063-6294a90af124 | 2026-01-04 | Warnings | M022 |
| Smile Paint | SODIUM FLUORIDE | JABBER JAW KIDS TOOTHPASTE LLC | a7463b5c-53b2-4353-a5ea-800fbd7bd17d | 2026-01-02 | Warnings | M022 |
| Dentek Canker Cover | MENTHOL | Bershtel Enterprises | 2669183c-7a58-037e-e054-00144ff88e88 | 2025-12-31 | Warnings | M022 |
| AutoBrush strawberry | SODIUM FLUORIDE | Lander Enterprises, LLC | 05929148-bffe-439f-a9d4-3170816c0fa2 | 2025-12-31 | Warnings | M022 |
| AutoBrush Watermelon | SODIUM FLUORIDE | Lander Enterprises, LLC | 37a4e712-e3b5-42f6-971c-98dea4b8dd06 | 2025-12-31 | Warnings | M022 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | 6bcd35f5-18ea-4fc8-84cd-06db73f38a1e | 2025-12-31 | Warnings | M022 |
| AutoBrush Bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | e7bf7e31-650d-4a1c-9100-48722344b201 | 2025-12-31 | Warnings | M022 |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | M022 |
| Sensitive Mint Tooth-paste | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | 1e5e8b24-8304-482c-ae80-73effcc345da | 2025-12-23 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | 34260c69-d829-46c0-b12a-5136ee073ba1 | 13 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 34260c69-d829-46c0-b12a-5136ee073ba1 | 13 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 34260c69-d829-46c0-b12a-5136ee073ba1 | 13 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 34260c69-d829-46c0-b12a-5136ee073ba1 | 13 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 34260c69-d829-46c0-b12a-5136ee073ba1 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0548-01 | 00135054801 | 1 TUBE in 1 CARTON (0135-0548-01) / 23 g in 1 TUBE | 1 tube | 2021-06-28 | 0000-00-00 | No | No | Current |
| 0135-0548-02 | 00135054802 | 1 TUBE in 1 CARTON (0135-0548-02) / 96.4 g in 1 TUBE | 1 tube | 2021-06-28 | 0000-00-00 | No | No | Current |