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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Space Jam Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company54cbfb09-8fd7-ef08-99fd-14fc019c81ff2024-11-14WarningsExact identifier
application number: M021
Colgate Kids Llama Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolivea7b02cb2-cfb3-7b35-42da-7924d156dcc32024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Clean MintSODIUM FLUORIDEColgate-Palmolive Company82bc1101-84d7-4e21-be9c-870ad88a4b7c2024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDECOLGATE PALMOLIVE COMPANYb6ca4ec7-5087-4693-82b7-199b44d7f9312024-11-13WarningsExact identifier
application number: M021
Listerine Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
application number: M021
Listerine Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLCee9a962d-83c7-4b13-bff6-140e48785e8a2024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint ShieldSODIUM FLUORIDEKenvue Brands LLCd69d2e0d-a3e3-4d95-992d-c0c59172b3a52024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDELG H&H Co.,Ltd.2697fa68-b991-ab09-e063-6394a90aec4c2024-11-01WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.2698d6d8-051b-6c10-e063-6394a90a94182024-11-01WarningsExact identifier
application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)SODIUM FLUORIDEMADE BY DENTISTS INC263c448b-728f-4370-bcdb-148d614d9b342024-10-30WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.17f589e9-f4ba-46d3-a345-db38f9a9067d2024-10-17WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
application number: M021
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
application number: M021
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDENavajo Manufacturing Company Inc.23851360-e30e-dd97-e063-6394a90a54742024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact 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