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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact 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