FDA.reportPublic FDA data

Crest 3D White Luxe

Product NDC
37000-862
11-digit product format
370000862
Labeler code
37000
Product ID
37000-862_48ea8786-3ce3-a637-e063-6294a90ab4a9
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-19
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Luxe
Brand name suffix
Diamond Strong
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090579Internal RxNorm lookup
1486338Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1420129-5460-4900-ac9a-356d2d7c60a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-862-012023-05-19Crest ® 3D White Luxe™ Diamond Strong
37000-862-012023-05-19Crest ® 3D White Luxe™ Diamond Strong
37000-862-022023-05-19Crest ® 3D White Luxe™ Diamond Strong
37000-862-022023-05-19Crest ® 3D White Luxe™ Diamond Strong
37000-862-012023-01-30Crest ® 3D White Luxe™ Diamond Strong
37000-862-012023-01-30Crest ® 3D White Luxe™ Diamond Strong
37000-862-022023-01-30Crest ® 3D White Luxe™ Diamond Strong
37000-862-022023-01-30Crest ® 3D White Luxe™ Diamond Strong
37000-862-012021-02-12Crest ® 3D White Luxe™ Diamond Strong
37000-862-012021-02-12Crest ® 3D White Luxe™ Diamond Strong
37000-862-022021-02-12Crest ® 3D White Luxe™ Diamond Strong
37000-862-022021-02-12Crest ® 3D White Luxe™ Diamond Strong
37000-862-012021-01-29Crest ® 3D White Luxe™ Diamond Strong
37000-862-012021-01-29Crest ® 3D White Luxe™ Diamond Strong
37000-862-022021-01-29Crest ® 3D White Luxe™ Diamond Strong
37000-862-022021-01-29Crest ® 3D White Luxe™ Diamond Strong

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-862-01Crest 3D White LuxeDiamond Strong473 mL in 1 BOTTLE, PLASTICRINSE47311
37000-862-02Crest 3D White LuxeDiamond Strong946 mL in 1 BOTTLE, PLASTICRINSE94611
37000-862-03Crest 3D White LuxeDiamond Strong2 in 1 CELLO PACKRINSE211
37000-862-03Crest 3D White LuxeDiamond Strong946 mL in 1 BOTTLERINSE94611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride IonACTIVE MOIETYQ80VPU408OCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-862CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 4 package rows20250309_c1420129-5460-4900-ac9a-356d2d7c60a2.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486338Crest 0.022 % (fluoride ion 0.01 % ) MouthwashPSNc1420129-5460-4900-ac9a-356d2d7c60a211
1090579sodium fluoride 0.0219 % (fluoride ion 0.01 % ) MouthwashPSNc1420129-5460-4900-ac9a-356d2d7c60a211
1486338sodium fluoride 0.22 MG/ML Mouthwash [Crest]SBDc1420129-5460-4900-ac9a-356d2d7c60a211
1090579sodium fluoride 0.22 MG/ML MouthwashSCDc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Crest 0.022 % (fluoride ion 0.01 % ) MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Crest 0.22 MG/ML MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Crest Pro-Health For Me 0.022 % (fluoride ion 0.01 % ) Oral RinseSYc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Crest Pro-Health For Me 0.22 MG/ML MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Crest Sensi-Care MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211
1486338Kids Crest Cavity Protection 0.22 MG/ML MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211
1090579sodium fluoride 0.0219 % (fluoride ion 0.01 % ) MouthwashSYc1420129-5460-4900-ac9a-356d2d7c60a211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-862-0137000086201473 mL in 1 BOTTLE, PLASTIC (37000-862-01) 473 ml2015-02-190000-00-00NoNoCurrent
37000-862-0237000086202946 mL in 1 BOTTLE, PLASTIC (37000-862-02) 946 ml2015-02-190000-00-00NoNoCurrent
37000-862-03370000862032 BOTTLE in 1 CELLO PACK (37000-862-03) / 946 mL in 1 BOTTLE2 bottle2015-02-19NoNoCurrent