FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
37000-867
Requested package NDC
37000-867-01
11-digit product format
370000867
Labeler code
37000
Product ID
37000-867_47e4a9bf-9cbb-4bc6-e063-6394a90abac4
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
2015-07-20
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 Pro-Health
Brand name suffix
Advanced w/Extra Whitening
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
313029Internal RxNorm lookup
1658137Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c1c5563-0b7e-4c7c-b49f-3d72e078cd28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-867-012023-05-19Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-05-19Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-05-19Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-05-19Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-01-30Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-01-30Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-01-30Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-01-30Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-02-12Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-02-12Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-02-12Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-02-12Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-01-29Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-01-29Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-01-29Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-01-29Crest ® Pro-Health™ Advanced Extra Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-867-01Crest Pro-HealthAdvanced w/Extra Whitening473 mL in 1 BOTTLE, PLASTICRINSE47311
37000-867-02Crest Pro-HealthAdvanced w/Extra Whitening946 mL in 1 BOTTLE, PLASTICRINSE94611
37000-867-29Crest Pro-HealthAdvanced w/Extra Whitening946 mL in 1 BOTTLE, PLASTICRINSE94611
37000-867-29Crest Pro-HealthAdvanced w/Extra Whitening2 in 1 CELLO PACKRINSE211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7CREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride ionACTIVE MOIETYQ80VPU408OCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-867CREST PRO-HEALTH ADVANCED W/EXTRA WHITENING (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 4 package rows20250309_2c1c5563-0b7e-4c7c-b49f-3d72e078cd28.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658137Crest 0.02 % MouthwashPSN2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
1658137sodium fluoride 0.2 MG/ML Mouthwash [Crest]SBD2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
313029sodium fluoride 0.2 MG/ML MouthwashSCD2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
1658137Crest 0.0219 % (fluoride ion 0.01 % ) Oral RinseSY2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
1658137Crest 0.2 MG/ML MouthwashSY2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
1658137Crest Pro-Health Advanced 0.02 % (0.01 % fluoride ion) MouthwashSY2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY2c1c5563-0b7e-4c7c-b49f-3d72e078cd2811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-867-0137000086701473 mL in 1 BOTTLE, PLASTIC (37000-867-01) 473 ml2015-07-200000-00-00NoNoCurrent