FDA.reportPublic FDA data

Crest 3D White

Product NDC
37000-916
11-digit product format
370000916
Labeler code
37000
Product ID
37000-916_47e4cccd-abff-efb8-e063-6294a90a64ce
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
2018-07-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37000-91637000-916-23DDiscontinued by firm2026-10-20
excluded packagepackage37000-91637000-916-39DDiscontinued by firm2026-10-20
excluded packagepackage37000-91637000-916-82DDiscontinued by firm2026-10-20

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 Blast
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
6d9a1754-8d38-054f-e053-2991aa0a4653Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-916-392023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-392023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-412023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-412023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-822023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-822023-03-30Crest ® 3D White ™ Brilliance Blast
37000-916-392023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-392023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-412023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-412023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-822023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-822023-01-30Crest ® 3D White ™ Brilliance Blast
37000-916-412021-02-12Crest ® 3D White ™ Brilliance Blast
37000-916-412021-02-12Crest ® 3D White ™ Brilliance Blast
37000-916-822021-02-12Crest ® 3D White ™ Brilliance Blast
37000-916-822021-02-12Crest ® 3D White ™ Brilliance Blast
37000-916-412021-01-29Crest ® 3D White ™ Brilliance Blast
37000-916-412021-01-29Crest ® 3D White ™ Brilliance Blast
37000-916-822021-01-29Crest ® 3D White ™ Brilliance Blast
37000-916-822021-01-29Crest ® 3D White ™ Brilliance Blast

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-916-23Crest 3D WhiteBrilliance Blast2 in 1 CARTONPASTE, DENTIFRICE212
37000-916-23Crest 3D WhiteBrilliance Blast110 g in 1 TUBEPASTE, DENTIFRICE11012
37000-916-35Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112
37000-916-35Crest 3D WhiteBrilliance Blast99 g in 1 TUBEPASTE, DENTIFRICE9912
37000-916-36Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112
37000-916-36Crest 3D WhiteBrilliance Blast2 in 1 CELLO PACKPASTE, DENTIFRICE212
37000-916-39Crest 3D WhiteBrilliance Blast110 g in 1 TUBEPASTE, DENTIFRICE11012
37000-916-39Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112
37000-916-41Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112
37000-916-41Crest 3D WhiteBrilliance Blast116 g in 1 TUBEPASTE, DENTIFRICE11612
37000-916-46Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112
37000-916-46Crest 3D WhiteBrilliance Blast130 g in 1 TUBEPASTE, DENTIFRICE13012
37000-916-82Crest 3D WhiteBrilliance Blast2 in 1 CELLO PACKPASTE, DENTIFRICE212
37000-916-82Crest 3D WhiteBrilliance Blast1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-916CREST 3D WHITE BRILLIANCE BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 14 package rows20250525_6d9a1754-8d38-054f-e053-2991aa0a4653.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 % ToothpastePSN6d9a1754-8d38-054f-e053-2991aa0a465312
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD6d9a1754-8d38-054f-e053-2991aa0a465312
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY6d9a1754-8d38-054f-e053-2991aa0a465312
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY6d9a1754-8d38-054f-e053-2991aa0a465312
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY6d9a1754-8d38-054f-e053-2991aa0a465312
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY6d9a1754-8d38-054f-e053-2991aa0a465312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-916-23370000916232 in 1 CARTONHistorical
37000-916-35370000916351 TUBE in 1 CARTON (37000-916-35) / 99 g in 1 TUBE1 tube2021-09-15NoNoCurrent
37000-916-36370000916362 CARTON in 1 CELLO PACK (37000-916-36) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE2 carton2018-07-01NoNoCurrent
37000-916-39370000916391 TUBE in 1 CARTON (37000-916-39) > 110 g in 1 TUBE1 tube2021-09-150000-00-00NoNoCurrent
37000-916-41370000916411 TUBE in 1 CARTON (37000-916-41) / 116 g in 1 TUBE1 tube2018-07-010000-00-00NoNoCurrent
37000-916-46370000916461 TUBE in 1 CARTON (37000-916-46) / 130 g in 1 TUBE1 tube2018-07-01NoNoCurrent
37000-916-82370000916822 CARTON in 1 CELLO PACK (37000-916-82) > 1 TUBE in 1 CARTON > 116 g in 1 TUBE2 carton2018-07-010000-00-00NoNoCurrent