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 firm2026-10-20
excluded packagepackage37000-86837000-868-06DDiscontinued by firm2026-10-20
excluded packagepackage37000-86837000-868-57DDiscontinued by firm2026-10-20

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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact 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