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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEDONG IL PHARMS CO.,LTD3fb1a2ee-381e-a9e8-e063-6394a90a864b2025-09-26WarningsExact identifier
application number: M021
unpa Cha Cha ToothpasteSODIUM MONOFLUOROPHOSPHATELycl Inc.230b3cf2-053a-4e8b-8d50-05bbc877faa82025-09-25WarningsExact identifier
application number: M021
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact identifier
application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.f70d378b-d4d6-454c-90a9-794459960c8c2025-09-17WarningsExact identifier
application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.26b9b2dd-7cb2-47c3-8bbb-94a48f02dd212025-09-16WarningsExact identifier
application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.3436532d-e078-4dbb-a823-b4542e9615342025-09-16WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
application number: M021
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
application number: M021
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
application number: M021
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
application number: M021
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.e911effb-d59f-4054-9501-803b64369ab42025-09-05WarningsExact identifier
application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc.fc794fe5-7135-4b2b-b002-a75908223f202025-08-13WarningsExact 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