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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact 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