FDA.reportPublic FDA data

SENSODYNE

Product NDC
0135-0547
11-digit product format
001350547
Labeler code
0135
Product ID
0135-0547_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 Extra Fresh
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34260c69-d829-46c0-b12a-5136ee073ba1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0547-02SENSODYNERepair and Protect Extra Fresh96.4 g in 1 TUBEPASTE96.413
0135-0547-02SENSODYNERepair and Protect Extra Fresh1 in 1 CARTONPASTE113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31SENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9SENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENSODYNE REPAIR AND PROTECT (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT EXTRA FRESH (STANNOUS FLUORIDE) PASTE SENSODYNE REPAIR AND PROTECT WHITENING (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0547SENSODYNE 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]13Current NDC, Legacy NDC, 2 package rows20240308_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.

Matched openFDA labels page 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wintergreen PeppermintPOTASSIUM NITRATE, SODIUM FLUORIDETwice Twice LLC7b7beec2-e070-4102-a2a4-68c332fc9fb32026-01-19WarningsExact identifier
application number: M022
GuruNanda SensitivePOTASSIUM NITRATEGURUNANDA, LLC3ef0d3d4-fd42-0181-e063-6394a90af09c2026-01-19WarningsExact identifier
application number: M022
Up and Up AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation386ee9f9-598e-ad00-e063-6394a90aeb462026-01-19WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company4a8f1d2f-b326-46d2-8914-d65ccc409edf2026-01-18WarningsExact identifier
application number: M022
Colgate Sensitive WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company3b656928-af58-4ee9-8fb8-360688eb9bf32026-01-13WarningsExact identifier
application number: M022
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
application number: M022
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
application number: M022
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
application number: M022
CVS Health Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
application number: M022
Moon Platinum Advanced Whitening AnticavitySODIUM FLUORIDEMoon Oral Care LLCded3a5a6-2883-f3de-e053-2a95a90afb942026-01-09WarningsExact identifier
application number: M022
Moon Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0bdcad3e-b8e9-bd91-e063-6394a90a666a2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive Prevent and RepairPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companye67410dc-a671-4611-8af1-097be071cd1c2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive plus WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company2092c747-e025-47a9-9e54-731631d3c8312026-01-09WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
application number: M022
Crest 3D White AdvancedSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf3aa9a59-b4d4-05d9-e053-2995a90a0aea2026-01-08Exact identifier
application number: M022
Oral B Plaque Defense Special Care Oral RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd503fad5-a378-0e60-e053-2a95a90abe652026-01-08WarningsExact identifier
application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All DayCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd5f69341-b659-c74a-e053-2a95a90a317e2026-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN34260c69-d829-46c0-b12a-5136ee073ba113
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD34260c69-d829-46c0-b12a-5136ee073ba113
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY34260c69-d829-46c0-b12a-5136ee073ba113
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY34260c69-d829-46c0-b12a-5136ee073ba113
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY34260c69-d829-46c0-b12a-5136ee073ba113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0547-02001350547021 TUBE in 1 CARTON (0135-0547-02) / 96.4 g in 1 TUBE1 tube2021-06-280000-00-00NoNoCurrent