FDA.reportPublic FDA data

Crest

Product NDC
37000-868
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

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 packagepackage37000-86837000-868-02DDiscontinued by firm2026-10-16
excluded packagepackage37000-86837000-868-06DDiscontinued by firm2026-10-16
excluded packagepackage37000-86837000-868-57DDiscontinued by firm2026-10-16

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-86837000-868-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-86837000-868-57DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37000-86837000-868-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, 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
37000-868-02370000868021 TUBE in 1 CARTON (37000-868-02) > 82 g in 1 TUBE1 tube2015-03-092021-12-01NoNoCurrent
37000-868-06370000868061 TUBE in 1 CARTON (37000-868-06) > 181 g in 1 TUBE1 tube2015-03-090000-00-00NoNoCurrent
37000-868-24370000868241 TUBE in 1 CARTON (37000-868-24) / 68 g in 1 TUBE1 tube2019-09-100000-00-00NoNoCurrent
37000-868-57370000868571 TUBE in 1 CARTON (37000-868-57) > 161 g in 1 TUBE1 tube2015-03-090000-00-00NoNoCurrent