FDA.reportPublic FDA data

Crest Tartar Protection

Product NDC
58933-008
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58933-00858933-008-02DDiscontinued by firm2026-10-16
excluded packagepackage58933-00858933-008-03DDiscontinued by firm2026-10-16
excluded packagepackage58933-00858933-008-04DDiscontinued by firm2026-10-16

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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
application number: M021
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
application number: M021
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact 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
58933-008-02589330008021 TUBE in 1 CARTON (58933-008-02) > 82 g in 1 TUBE1 tube1992-11-060000-00-00NoNoCurrent
58933-008-03589330008031 TUBE in 1 CARTON (58933-008-03) > 130 g in 1 TUBE1 tube1992-11-060000-00-00NoNoCurrent
58933-008-04589330008041 TUBE in 1 CARTON (58933-008-04) > 181 g in 1 TUBE1 tube1992-11-060000-00-00NoNoCurrent
58933-008-24589330008241 TUBE in 1 CARTON (58933-008-24) / 68 g in 1 TUBE1 tube2021-09-10NoNoCurrent
58933-008-57589330008571 TUBE in 1 CARTON (58933-008-57) / 161 g in 1 TUBE1 tube2021-09-100000-00-00NoNoCurrent