FDA.reportPublic FDA data

Sensodyne Complete Protection

Product NDC
0135-0572
11-digit product format
001350572
Labeler code
0135
Product ID
0135-0572_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
Brand name suffix
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
e3cc3146-8aed-4f6b-a252-e379418c2b8dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0572-022024-01-30C16284748780-11030e365-0e84-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0572-02Sensodyne Complete ProtectionExtra Fresh96.4 g in 1 TUBEPASTE96.410
0135-0572-02Sensodyne Complete ProtectionExtra Fresh1 in 1 CARTONPASTE110
0135-0572-03Sensodyne Complete ProtectionExtra Fresh96. g in 1 TUBEPASTE96.10
0135-0572-03Sensodyne Complete ProtectionExtra Fresh2 in 1 CARTONPASTE210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0572-02GM - Gram0135-05726721fcb8-569c-4f61-bd74-6eb34eab168312018-02-20

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
0135-0572SENSODYNE 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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact 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
0135-0572-02001350572021 TUBE in 1 CARTON (0135-0572-02) / 96.4 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
0135-0572-03001350572032 TUBE in 1 CARTON (0135-0572-03) / 96 g in 1 TUBE2 tube2024-04-01NoNoCurrent