FDA.reportPublic FDA data

Sensodyne Complete Protection

Product NDC
0135-0573
11-digit product format
001350573
Labeler code
0135
Product ID
0135-0573_78b76a64-361a-41e8-aead-29ac143c0901
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-14
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 Complete Protection
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
e3cc3146-8aed-4f6b-a252-e379418c2b8dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0573-022024-01-30C16284748780-11030e365-0e84-111a-e063-dadaa90a10e2Drug Facts
0135-0573-032024-01-30C16284748780-11030e365-0e84-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0573-02Sensodyne Complete Protection96.4 g in 1 TUBEPASTE96.410
0135-0573-02Sensodyne Complete Protection1 in 1 CARTONPASTE110
0135-0573-03Sensodyne Complete Protection23 g in 1 TUBEPASTE2310
0135-0573-03Sensodyne Complete Protection1 in 1 CARTONPASTE110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
SODIUM TRIPOLYPHOSPHATE ANHYDROUSINACTIVE INGREDIENT9SW4PFD2FZSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0573SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE SENSODYNE COMPLETE PROTECTION EXTRA FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 4 package rows20250328_e3cc3146-8aed-4f6b-a252-e379418c2b8d.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNe3cc3146-8aed-4f6b-a252-e379418c2b8d10
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDe3cc3146-8aed-4f6b-a252-e379418c2b8d10
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYe3cc3146-8aed-4f6b-a252-e379418c2b8d10
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYe3cc3146-8aed-4f6b-a252-e379418c2b8d10
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYe3cc3146-8aed-4f6b-a252-e379418c2b8d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0573-02001350573021 TUBE in 1 CARTON (0135-0573-02) / 96.4 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
0135-0573-03001350573031 TUBE in 1 CARTON (0135-0573-03) / 23 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent