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

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 1 of 42 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact 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