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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEBb76c3591-6383-4661-b3db-7a56b11202f72026-01-08WarningsExact 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