FDA.reportPublic FDA data

Crest 3D White Brilliance

Product NDC
37000-863
11-digit product format
370000863
Labeler code
37000
Product ID
37000-863_47e4a85d-a3e6-ba6a-e063-6294a90a251d
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
KIT
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-05
NDC exclude flag
No
Listing certified through
2027-12-31
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
Crest 3D White Brilliance
Brand name suffix
Daily Cleansing and Whitening System
Listing expiration
2027-12-31

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
89a6fb36-5109-47f1-95ad-9381471ceeefAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-30Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2023-03-30Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2023-01-30Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2023-01-30Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2021-02-12Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2021-02-12Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2021-01-29Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System
2021-01-29Crest ® 3D White™ Brilliance Daily Cleansing and Whitening System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-863-04Crest 3D White BrillianceDaily Cleansing and Whitening System1 in 1 CARTONKIT19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Stannous FluorideACTIVE INGREDIENT3FTR44B32QCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride IonACTIVE MOIETYQ80VPU408OCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
micaINACTIVE INGREDIENTV8A1AW0880CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium gluconateINACTIVE INGREDIENTR6Q3791S76CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEECREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
zinc lactateINACTIVE INGREDIENT2GXR25858YCREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-863CREST 3D WHITE BRILLIANCE DAILY CLEANSING AND WHITENING SYSTEM (STANNOUS FLUORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 1 package rows20250116_89a6fb36-5109-47f1-95ad-9381471ceeef.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 33 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB HEBuddyFLUORIDEHEBa6af1baf-17bf-428c-8744-1490359b0cfb2025-11-13WarningsExact identifier
application number: M021
Spearmint Whitening with Hemp OilSODIUM MONOFLUOROPHOSPHATEWhole Foodsa4714db7-abc4-1eff-e053-2995a90a77402025-11-13WarningsExact identifier
application number: M021
Complete Protection TPSTANNOUS FLUORIDERite Aidccad28b5-254e-679f-e053-2a95a90abdd52025-11-13WarningsExact identifier
application number: M021
Rite Aid Sensitivity and GumSTANNOUS FLUORIDERite Aided362e9c-2dab-1102-e053-2a95a90a76f32025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEMeijer, Inc.0338495b-08a5-047f-e063-6394a90aa1242025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDECVSb673f6cc-ae70-7161-e053-2a95a90af8cd2025-11-13WarningsExact identifier
application number: M021
CVS Sens WhtngSTANNOUS FLUORIDECVScba7a512-03bc-8ebc-e053-2995a90ae12b2025-11-13WarningsExact identifier
application number: M021
Equate Repair and ProtectSTANNOUS FLUORIDEWalmartc4807b2b-7ea9-cc28-e053-2995a90a348e2025-11-13WarningsExact identifier
application number: M021
Kids Strawberry FTPSODIUM MONOFLUOROPHOSPHATETarget253c7c90-5d82-b1e0-e063-6394a90a7a4b2025-11-13WarningsExact identifier
application number: M021
Sensitivity and GumSTANNOUS FLUORIDEDG Health (Rexall)039c6e46-f995-c744-e063-6294a90a537e2025-11-13WarningsExact identifier
application number: M021
Equate Optimal Care TP Equate Optimal Care TPSTANNOUS FLUORIDEWalmart Inc.1e65b83e-a51a-4adb-e063-6394a90a06b42025-11-13WarningsExact identifier
application number: M021
Sensitive Whitening AnticavitySTANNOUS FLOURIDETopco96384c9d-cb42-7654-e053-2995a90aac082025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDERite Aidccad4383-4479-6175-e053-2a95a90a13a22025-11-13WarningsExact identifier
application number: M021
Restore and Defend Whitening TPSTANNOUS FLUORIDEKroger253ba5c0-f2ef-46e6-e063-6394a90ad9d52025-11-13WarningsExact identifier
application number: M021
Dr Tichenors With Extra Whitening and Tartar ControlSODIUM FLUORIDEDr. G. H. Tichenor's Antiseptic Companybce596e8-07eb-4e56-9007-9d283e14372d2025-11-12WarningsExact identifier
application number: M021
Kids Silly Strawberry TPSODIUM MONOFLUOROPHOSPHATEHEBab361305-01f9-7379-e053-2995a90a97b42025-11-12WarningsExact identifier
application number: M021
Care One Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEFoodhold U.S.A.81a380eb-8605-b280-e053-2a91aa0abd4b2025-11-12WarningsExact identifier
application number: M021
365 Everyday Value Kids FlourideSODIUM MONOFLUOROPHOSPHATEWhole Foods Market, Inc.836f2df8-00b6-ff2d-e053-2991aa0a89582025-11-12WarningsExact identifier
application number: M021
CVS Rapid Protection SensitiveSTANNOUS FLUORIDECVS Pharmacy8162fcc0-7a24-678c-e053-2a91aa0af2fe2025-11-12WarningsExact identifier
application number: M021
Rite Aid Sensitive Rapid ProtectionSTANNOUS FLUORIDERite Aid8335dd4d-62a0-6861-e053-2a91aa0a82832025-11-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN89a6fb36-5109-47f1-95ad-9381471ceeef9
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD89a6fb36-5109-47f1-95ad-9381471ceeef9
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY89a6fb36-5109-47f1-95ad-9381471ceeef9
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY89a6fb36-5109-47f1-95ad-9381471ceeef9
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY89a6fb36-5109-47f1-95ad-9381471ceeef9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-863-04370000863041 KIT in 1 CARTON (37000-863-04) * 113 g in 1 TUBE * 65 g in 1 TUBE1 kit2015-02-050000-00-00NoNoCurrent