FDA.reportPublic FDA data

Crest

Product NDC
58933-868
11-digit product format
589330868
Labeler code
58933
Product ID
58933-868_47e55ea2-1115-0daa-e063-6394a90ababc
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manufactura, S. de R.L. de C.V.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-09
Substance
SODIUM FLUORIDE
Active strength
1.5 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 packagepackage58933-86858933-868-02DDiscontinued by firm2026-10-20

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
Brand name suffix
Fresh and White
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 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
5a1bb1fb-12a5-5fd1-e053-2991aa0a628bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-15Crest ® Fresh and White
2023-05-15Crest ® Fresh and White
2023-01-30Crest ® Fresh and White
2023-01-30Crest ® Fresh and White
2021-06-10Crest ® Fresh and White
2021-06-10Crest ® Fresh and White
2021-01-29Crest ® Fresh and White
2021-01-29Crest ® Fresh and White

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-868-02CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE19
58933-868-02CrestFresh and White82 g in 1 TUBEPASTE, DENTIFRICE829
58933-868-24CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE19
58933-868-24CrestFresh and White68 g in 1 TUBEPASTE, DENTIFRICE689

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-868CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.]7Current NDC, Legacy NDC, 4 package rows20250110_5a1bb1fb-12a5-5fd1-e053-2991aa0a628b.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 % ToothpastePSN5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY5a1bb1fb-12a5-5fd1-e053-2991aa0a628b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-868-02589330868021 TUBE in 1 CARTON (58933-868-02) > 82 g in 1 TUBE1 tube2015-03-090000-00-00NoNoCurrent
58933-868-24589330868241 TUBE in 1 CARTON (58933-868-24) / 68 g in 1 TUBE1 tube2015-03-09NoNoCurrent