FDA.reportPublic FDA data

Crest

Product NDC
37000-868
Requested package NDC
37000-868-24
11-digit product format
370000868
Labeler code
37000
Product ID
37000-868_4aa60484-78be-875c-e063-6294a90ab84f
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
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

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
8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-868-022021-02-12Crest ® Fresh and White
37000-868-022021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-022021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-022021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-02-12Crest ® Fresh and White
37000-868-062021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-02-12Crest ® Fresh and White
37000-868-242021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-02-12Crest Fresh and White Peppermint Gleem Paste
37000-868-022021-01-29Crest ® Fresh and White
37000-868-022021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-022021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-022021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-01-29Crest ® Fresh and White
37000-868-062021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-062021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-01-29Crest ® Fresh and White
37000-868-242021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-01-29Crest Fresh and White Peppermint Gleem Paste
37000-868-242021-01-29Crest Fresh and White Peppermint Gleem Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-868-02CrestFresh and White82 g in 1 TUBEPASTE, DENTIFRICE8212
37000-868-02CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE112
37000-868-06CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE112
37000-868-06CrestFresh and White181 g in 1 TUBEPASTE, DENTIFRICE18112
37000-868-24CrestFresh and White68 g in 1 TUBEPASTE, DENTIFRICE6812
37000-868-24CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE112
37000-868-57CrestFresh and White161 g in 1 TUBEPASTE, DENTIFRICE16112
37000-868-57CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride IonACTIVE MOIETYQ80VPU408OCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-868CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 8 package rows20250110_8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e.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 % ToothpastePSN8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-868-24370000868241 TUBE in 1 CARTON (37000-868-24) / 68 g in 1 TUBE1 tube2019-09-100000-00-00NoNoCurrent