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 firm2026-10-15
excluded packagepackage37000-86837000-868-06DDiscontinued by firm2026-10-15
excluded packagepackage37000-86837000-868-57DDiscontinued by firm2026-10-15

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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact 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