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 firm2026-10-12
excluded packagepackage37000-91637000-916-39DDiscontinued by firm2026-10-12
excluded packagepackage37000-91637000-916-82DDiscontinued by firm2026-10-12

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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact 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