Crest 3D White

Product NDC
69423-853
11-digit product format
694230853
Labeler code
69423
Product ID
69423-853_47e3b94b-a5a6-644a-e063-6294a90ac248
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-27
Substance
SODIUM FLUORIDE
Active strength
1.6 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-85369423-853-05DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-85369423-853-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Brand name suffix
Advanced Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d218ddc0-1d5f-f39b-e053-2995a90a96edAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-853-05Crest 3D WhiteAdvanced Whitening5 in 1 CELLO PACKPASTE, DENTIFRICE57
69423-853-05Crest 3D WhiteAdvanced Whitening1 in 1 CARTONPASTE, DENTIFRICE17
69423-853-52Crest 3D WhiteAdvanced Whitening147 g in 1 TUBEPASTE, DENTIFRICE1477
69423-853-52Crest 3D WhiteAdvanced Whitening1 in 1 CARTONPASTE, DENTIFRICE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-853CREST 3D WHITE ADVANCED WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC, 4 package rows20250110_d218ddc0-1d5f-f39b-e053-2995a90a96ed.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 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Ipana Wintergreen FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Inc.5776cc3e-4fd1-4bd7-8d82-f82508e6b8d02025-07-28WarningsExact identifier
application number: M021
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
application number: M021
Dubai Chocolate FlavorANTICAVITY TOOTHPASTESuperMouth, LLC.d1615a53-ecfc-49d1-b836-f7643b9d26602025-07-24WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
application number: M021
Dubai Chocolate Fluoride MouthwashANTICAVITY MOUTHWASHSuperMouth, LLC.ef81a983-64c1-4913-9235-25451f0238522025-07-23WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.3409a749-4a1a-4950-8c21-364d1b977af72025-07-22WarningsExact identifier
application number: M021
Act Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.dc209500-2bf4-42fb-b3a1-d0fb8d63dbd82025-07-22WarningsExact identifier
application number: M021
Brush Buddies Oral Rinse Sparkle MintSODIUM FLUORIDEASHTEL STUDIOS, INCfe2c06fc-6497-4888-877f-1a88e02fad202025-07-15WarningsExact identifier
application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.1620c7fa-2af6-4462-af5d-9e122942788a2025-07-15WarningsExact identifier
application number: M021
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.13dba3ce-88a8-490c-a906-cfd206d1d2902025-07-01WarningsExact identifier
application number: M021
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.baae4f4a-54ef-472a-9c94-31703435750b2025-07-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNd218ddc0-1d5f-f39b-e053-2995a90a96ed7
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDd218ddc0-1d5f-f39b-e053-2995a90a96ed7
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYd218ddc0-1d5f-f39b-e053-2995a90a96ed7
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYd218ddc0-1d5f-f39b-e053-2995a90a96ed7
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYd218ddc0-1d5f-f39b-e053-2995a90a96ed7
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYd218ddc0-1d5f-f39b-e053-2995a90a96ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-853-05694230853055 CARTON in 1 CELLO PACK (69423-853-05) > 1 TUBE in 1 CARTON > 147 g in 1 TUBE5 carton2021-12-270000-00-00NoNoCurrent
69423-853-52694230853521 TUBE in 1 CARTON (69423-853-52) / 147 g in 1 TUBE1 tube2021-12-270000-00-00NoNoCurrent