Crest Pro-Health

Product NDC
37000-867
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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1658137

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-867-012023-05-19C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-05-19C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-05-19C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-05-19C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-01-30C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012023-01-30C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-01-30C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022023-01-30C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-02-12C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-02-12C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-02-12C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-02-12C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-01-29C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-012021-01-29C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-01-29C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® Pro-Health™ Advanced Extra Whitening
37000-867-022021-01-29C16284748780-1ba0f9c33-1e9b-a910-e053-dadaa90a0b85Crest ® 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

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
37000-867-0237000086702946 mL in 1 BOTTLE, PLASTIC (37000-867-02) 946 ml2015-07-200000-00-00NoNoCurrent
37000-867-29370000867292 BOTTLE, PLASTIC in 1 CELLO PACK (37000-867-29) / 946 mL in 1 BOTTLE, PLASTIC2015-07-20NoNoHistorical