FDA.reportPublic FDA data

Crest Tartar Protection

Product NDC
58933-008
Requested package NDC
58933-008-03
11-digit product format
589330008
Labeler code
58933
Product ID
58933-008_47e54e5e-4bd4-00ce-e063-6394a90a99e8
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
1992-11-06
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 packagepackage58933-00858933-008-03DDiscontinued by firm2026-10-05

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 Tartar Protection
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
5940711d-71b7-cb7d-e053-2a91aa0aef18Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58933-008-022023-05-17Crest ® Tartar Protection
58933-008-022023-05-17Crest ® Tartar Protection
58933-008-032023-05-17Crest ® Tartar Protection
58933-008-032023-05-17Crest ® Tartar Protection
58933-008-042023-05-17Crest ® Tartar Protection
58933-008-042023-05-17Crest ® Tartar Protection
58933-008-572023-05-17Crest ® Tartar Protection
58933-008-572023-05-17Crest ® Tartar Protection
58933-008-022023-01-30Crest ® Tartar Protection
58933-008-022023-01-30Crest ® Tartar Protection
58933-008-032023-01-30Crest ® Tartar Protection
58933-008-032023-01-30Crest ® Tartar Protection
58933-008-042023-01-30Crest ® Tartar Protection
58933-008-042023-01-30Crest ® Tartar Protection
58933-008-572023-01-30Crest ® Tartar Protection
58933-008-572023-01-30Crest ® Tartar Protection
58933-008-022021-06-10Crest ® Tartar Protection
58933-008-022021-06-10Crest ® Tartar Protection
58933-008-032021-06-10Crest ® Tartar Protection
58933-008-032021-06-10Crest ® Tartar Protection
58933-008-042021-06-10Crest ® Tartar Protection
58933-008-042021-06-10Crest ® Tartar Protection
58933-008-022021-01-29Crest ® Tartar Protection
58933-008-022021-01-29Crest ® Tartar Protection
58933-008-032021-01-29Crest ® Tartar Protection
58933-008-032021-01-29Crest ® Tartar Protection
58933-008-042021-01-29Crest ® Tartar Protection
58933-008-042021-01-29Crest ® Tartar Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-008-02Crest Tartar Protection82 g in 1 TUBEPASTE, DENTIFRICE8212
58933-008-02Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-03Crest Tartar Protection130 g in 1 TUBEPASTE, DENTIFRICE13012
58933-008-03Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-04Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-04Crest Tartar Protection181 g in 1 TUBEPASTE, DENTIFRICE18112
58933-008-24Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-24Crest Tartar Protection68 g in 1 TUBEPASTE, DENTIFRICE6812
58933-008-57Crest Tartar Protection161 g in 1 TUBEPASTE, DENTIFRICE16112
58933-008-57Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-008CREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.]9Current NDC, Legacy NDC, 10 package rows20240207_5940711d-71b7-cb7d-e053-2a91aa0aef18.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN5940711d-71b7-cb7d-e053-2a91aa0aef1812
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD5940711d-71b7-cb7d-e053-2a91aa0aef1812
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY5940711d-71b7-cb7d-e053-2a91aa0aef1812
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY5940711d-71b7-cb7d-e053-2a91aa0aef1812
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY5940711d-71b7-cb7d-e053-2a91aa0aef1812
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY5940711d-71b7-cb7d-e053-2a91aa0aef1812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-008-03589330008031 TUBE in 1 CARTON (58933-008-03) > 130 g in 1 TUBE1 tube1992-11-060000-00-00NoNoCurrent