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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact 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