FDA.reportPublic FDA data

Crest Tartar Protection

Product NDC
37000-008
Requested package NDC
37000-008-04
11-digit product format
370000008
Labeler code
37000
Product ID
37000-008_47e4ba8f-0f17-ec5b-e063-6294a90af0cb
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
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 packagepackage37000-00837000-008-04DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
85477763-1db5-482f-90e5-e71f5c1b4765Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-008-022021-02-12Crest ® Tartar Protection
37000-008-022021-02-12Crest ® Tartar Protection
37000-008-022021-02-12Crest ® Tartar Protection
37000-008-032021-02-12Crest ® Tartar Protection
37000-008-032021-02-12Crest ® Tartar Protection
37000-008-032021-02-12Crest ® Tartar Protection
37000-008-042021-02-12Crest ® Tartar Protection
37000-008-042021-02-12Crest ® Tartar Protection
37000-008-042021-02-12Crest ® Tartar Protection
37000-008-242021-02-12Crest ® Tartar Protection
37000-008-242021-02-12Crest ® Tartar Protection
37000-008-242021-02-12Crest ® Tartar Protection
37000-008-422021-02-12Crest ® Tartar Protection
37000-008-422021-02-12Crest ® Tartar Protection
37000-008-422021-02-12Crest ® Tartar Protection
37000-008-572021-02-12Crest ® Tartar Protection
37000-008-572021-02-12Crest ® Tartar Protection
37000-008-572021-02-12Crest ® Tartar Protection
37000-008-022021-01-29Crest ® Tartar Protection
37000-008-022021-01-29Crest ® Tartar Protection
37000-008-022021-01-29Crest ® Tartar Protection
37000-008-032021-01-29Crest ® Tartar Protection
37000-008-032021-01-29Crest ® Tartar Protection
37000-008-032021-01-29Crest ® Tartar Protection
37000-008-042021-01-29Crest ® Tartar Protection
37000-008-042021-01-29Crest ® Tartar Protection
37000-008-042021-01-29Crest ® Tartar Protection
37000-008-242021-01-29Crest ® Tartar Protection
37000-008-242021-01-29Crest ® Tartar Protection
37000-008-242021-01-29Crest ® Tartar Protection
37000-008-422021-01-29Crest ® Tartar Protection
37000-008-422021-01-29Crest ® Tartar Protection
37000-008-422021-01-29Crest ® Tartar Protection
37000-008-572021-01-29Crest ® Tartar Protection
37000-008-572021-01-29Crest ® Tartar Protection
37000-008-572021-01-29Crest ® Tartar Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-008-02Crest Tartar Protection82 g in 1 TUBEPASTE, DENTIFRICE8213
37000-008-02Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113
37000-008-03Crest Tartar Protection130 g in 1 TUBEPASTE, DENTIFRICE13013
37000-008-03Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113
37000-008-04Crest Tartar Protection181 g in 1 TUBEPASTE, DENTIFRICE18113
37000-008-04Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113
37000-008-24Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113
37000-008-24Crest Tartar Protection68 g in 1 TUBEPASTE, DENTIFRICE6813
37000-008-42Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113
37000-008-42Crest Tartar Protection119 g in 1 TUBEPASTE, DENTIFRICE11913
37000-008-57Crest Tartar Protection161 g in 1 TUBEPASTE, DENTIFRICE16113
37000-008-57Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7CREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride IonACTIVE MOIETYQ80VPU408OCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM ACID PYROPHOSPHATEINACTIVE INGREDIENTH5WVD9LZUDCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-008CREST TARTAR PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]11Current NDC, Legacy NDC, 12 package rows20250110_85477763-1db5-482f-90e5-e71f5c1b4765.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 % ToothpastePSN85477763-1db5-482f-90e5-e71f5c1b476513
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD85477763-1db5-482f-90e5-e71f5c1b476513
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY85477763-1db5-482f-90e5-e71f5c1b476513
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY85477763-1db5-482f-90e5-e71f5c1b476513
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY85477763-1db5-482f-90e5-e71f5c1b476513
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY85477763-1db5-482f-90e5-e71f5c1b476513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-008-04370000008041 TUBE in 1 CARTON (37000-008-04) > 181 g in 1 TUBE1 tube2021-10-010000-00-00NoNoCurrent