SENSODYNE

Product NDC
0135-0575
11-digit product format
001350575
Labeler code
0135
Product ID
0135-0575_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

Additional Listing Data#

Finished product
Yes
Brand name base
SENSODYNE
Brand name suffix
Repair and Protect Whitening
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0575-01SENSODYNERepair and Protect Whitening1 in 1 CARTONPASTE113
0135-0575-01SENSODYNERepair and Protect Whitening96.4 g in 1 TUBEPASTE96.413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0575-01GM - Gram0135-057541a0cbe0-41d1-45a6-b105-5039b8dd6fca12017-03-06

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
0135-0575SENSODYNE 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

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
0135-0575-01001350575011 TUBE in 1 CARTON (0135-0575-01) / 96.4 g in 1 TUBE1 tube2021-06-280000-00-00NoNoCurrent