FDA.reportPublic FDA data

Crest 3D White

Product NDC
37000-873
11-digit product format
370000873
Labeler code
37000
Product ID
37000-873_47e49f8f-fd96-9aa4-e063-6294a90a5e29
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
2015-07-06
Substance
SODIUM FLUORIDE
Active strength
1.6 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37000-87337000-873-04DDiscontinued by firm2026-10-16
excluded packagepackage37000-87337000-873-08DDiscontinued by firm2026-10-16
excluded packagepackage37000-87337000-873-12DDiscontinued by firm2026-10-16
excluded packagepackage37000-87337000-873-52DDiscontinued by firm2026-10-16
excluded packagepackage37000-87337000-873-78DDiscontinued 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 · 5 matching rows.

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

Package NDC table
Package NDC
37000-873-12
37000-873-78
37000-873-52
37000-873-08
37000-873-04

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 3D White
Brand name suffix
Brilliance
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 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
8e189fbd-5094-4398-b96c-8f95d89b9cddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-873-04Crest 3D WhiteBrilliance116 g in 1 TUBEPASTE, DENTIFRICE11621
37000-873-04Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-08Crest 3D WhiteBrilliance2 in 1 CELLO PACKPASTE, DENTIFRICE221
37000-873-08Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-12Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-12Crest 3D WhiteBrilliance3 in 1 CELLO PACKPASTE, DENTIFRICE321
37000-873-23Crest 3D WhiteBrilliance2 in 1 CELLO PACKPASTE, DENTIFRICE221
37000-873-23Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-24Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-24Crest 3D WhiteBrilliance68 g in 1 TUBEPASTE, DENTIFRICE6821
37000-873-27Crest 3D WhiteBrilliance76 g in 1 TUBEPASTE, DENTIFRICE7621
37000-873-27Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-34Crest 3D WhiteBrilliance3 in 1 CARTONPASTE, DENTIFRICE321
37000-873-34Crest 3D WhiteBrilliance130 g in 1 TUBEPASTE, DENTIFRICE13021
37000-873-35Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-35Crest 3D WhiteBrilliance99 g in 1 TUBEPASTE, DENTIFRICE9921
37000-873-39Crest 3D WhiteBrilliance110 g in 1 TUBEPASTE, DENTIFRICE11021
37000-873-39Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-42Crest 3D WhiteBrilliance2 in 1 CARTONPASTE, DENTIFRICE221
37000-873-42Crest 3D WhiteBrilliance130 g in 1 TUBEPASTE, DENTIFRICE13021
37000-873-46Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-46Crest 3D WhiteBrilliance130 g in 1 TUBEPASTE, DENTIFRICE13021
37000-873-52Crest 3D WhiteBrilliance147 g in 1 TUBEPASTE, DENTIFRICE14721
37000-873-52Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-78Crest 3D WhiteBrilliance221 g in 1 TUBEPASTE, DENTIFRICE22121
37000-873-78Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-85Crest 3D WhiteBrilliance24 g in 1 TUBEPASTE, DENTIFRICE2421
37000-873-85Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-93Crest 3D WhiteBrilliance1 in 1 CARTONPASTE, DENTIFRICE121
37000-873-93Crest 3D WhiteBrilliance3 in 1 CELLO PACKPASTE, DENTIFRICE321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-873CREST 3D WHITE BRILLIANCE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]18Current NDC, Legacy NDC, 30 package rows20250116_8e189fbd-5094-4398-b96c-8f95d89b9cdd.zip
37000-873DELTA ONE 2019 TUMI COLLINS AND TUMI COLLINS BOMBAS AMENITY WITH CREST 3D WHITE BRILLIANCE (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Current NDC, Legacy NDC20211228_cbf8e13e-a12d-408d-bc6f-39846a31b564.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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Clean Breath PeppermintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ef07b-ee68-e6ae-e063-6394a90af5e52026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsExact identifier
application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4146d-6281-fe66-e063-6394a90a32c32026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef5261e-9d2f-ae05-e063-6294a90a489a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening UpkeepSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0876d9-41c9-d891-e063-6394a90a1cbd2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef57a05-b9f5-42f7-e063-6294a90a5d892026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ee26a82-16fd-f0fb-e063-6394a90a91d12026-04-09WarningsExact identifier
application number: M021
Crest 3D White Whitening Therapy Deep Clean CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company812c1519-1a4b-2495-e053-2a91aa0a914a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4e7c2-1f58-59fc-e063-6294a90ad43b2026-04-08WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited4ef669b9-defe-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c89efc-5fa0-2a05-e053-2a95a90a7b9c2026-04-07WarningsExact identifier
application number: M021
Crest 3D White Advanced CharcoalSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4eb8111-53da-17ae-e053-2a95a90a11272026-04-07WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLC35385ada-bd8d-4d38-9587-0256885f749f2026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLCcf0c8b48-0d1c-406a-a67d-7d16187d38d82026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Arctic FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfa08a877-b9e5-4eba-b832-3a28f4f3f83c2026-04-07WarningsExact identifier
application number: M021
Anticavity FluorideSODIUM FLUORIDEFamily Dollar (FAMILY WELLNESS)63c4c0e9-84b1-4076-bdf4-7e9543b2cf462026-04-01WarningsExact identifier
application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.98a8cee8-9f3c-4a4a-89f8-72e1f1b067962026-04-01WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN8e189fbd-5094-4398-b96c-8f95d89b9cdd21
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD8e189fbd-5094-4398-b96c-8f95d89b9cdd21
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY8e189fbd-5094-4398-b96c-8f95d89b9cdd21
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY8e189fbd-5094-4398-b96c-8f95d89b9cdd21
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY8e189fbd-5094-4398-b96c-8f95d89b9cdd21
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY8e189fbd-5094-4398-b96c-8f95d89b9cdd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-873-04370000873041 TUBE in 1 CARTON (37000-873-04) > 116 g in 1 TUBE1 tube2015-07-060000-00-00NoNoCurrent
37000-873-08370000873082 CARTON in 1 CELLO PACK (37000-873-08) > 1 TUBE in 1 CARTON > 116 g in 1 TUBE2 carton2015-07-060000-00-00NoNoCurrent
37000-873-12370000873123 CARTON in 1 CELLO PACK (37000-873-12) > 1 TUBE in 1 CARTON > 116 g in 1 TUBE3 carton2015-07-060000-00-00NoNoCurrent
37000-873-23370000873232 CARTON in 1 CELLO PACK (37000-873-23) / 1 TUBE in 1 CARTON / 110 g in 1 TUBE2 carton2015-07-06NoNoCurrent
37000-873-24370000873241 TUBE in 1 CARTON (37000-873-24) / 68 g in 1 TUBE1 tube2015-07-06NoNoCurrent
37000-873-27370000873271 TUBE in 1 CARTON (37000-873-27) / 76 g in 1 TUBE1 tube2021-01-050000-00-00NoNoCurrent
37000-873-34370000873343 TUBE in 1 CARTON (37000-873-34) / 130 g in 1 TUBE3 tube2015-07-06NoNoCurrent
37000-873-35370000873351 TUBE in 1 CARTON (37000-873-35) / 99 g in 1 TUBE1 tube2015-07-06NoNoCurrent
37000-873-363700008733624 g in 1 TUBE (37000-873-36) 24 g2015-07-060000-00-00NoNoCurrent
37000-873-39370000873391 TUBE in 1 CARTON (37000-873-39) / 110 g in 1 TUBE1 tube2021-01-050000-00-00NoNoCurrent
37000-873-42370000873422 TUBE in 1 CARTON (37000-873-42) / 130 g in 1 TUBE2 tube2015-07-06NoNoCurrent
37000-873-46370000873461 TUBE in 1 CARTON (37000-873-46) / 130 g in 1 TUBE1 tube2015-07-06NoNoCurrent
37000-873-52370000873521 TUBE in 1 CARTON (37000-873-52) > 147 g in 1 TUBE1 tube2021-02-110000-00-00NoNoCurrent
37000-873-7837000087378221 g in 1 TUBE221 gHistorical
37000-873-85370000873851 TUBE in 1 CARTON (37000-873-85) / 24 g in 1 TUBE1 tube2015-07-060000-00-00NoNoCurrent
37000-873-93370000873933 CARTON in 1 CELLO PACK (37000-873-93) / 1 TUBE in 1 CARTON / 110 g in 1 TUBE3 carton2015-07-06NoNoCurrent