FDA.reportPublic FDA data

Crest

Product NDC
69423-875
11-digit product format
694230875
Labeler code
69423
Product ID
69423-875_47e495e8-478e-b045-e063-6294a90a438e
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
STANNOUS FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crest
Brand name suffix
Densify Daily Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-875-41CrestDensify Daily Whitening1 in 1 CARTONPASTE, DENTIFRICE16
69423-875-41CrestDensify Daily Whitening116 g in 1 TUBEPASTE, DENTIFRICE1166
69423-875-53CrestDensify Daily Whitening1 in 1 CARTONPASTE, DENTIFRICE16
69423-875-53CrestDensify Daily Whitening150 g in 1 TUBEPASTE, DENTIFRICE1506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-875CREST DENSIFY DAILY WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 4 package rows20250227_d811306f-4994-7a5a-e053-2995a90adf16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd811306f-4994-7a5a-e053-2995a90adf166
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd811306f-4994-7a5a-e053-2995a90adf166
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd811306f-4994-7a5a-e053-2995a90adf166
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd811306f-4994-7a5a-e053-2995a90adf166
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd811306f-4994-7a5a-e053-2995a90adf166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-875-41694230875411 TUBE in 1 CARTON (69423-875-41) / 116 g in 1 TUBE1 tube2022-01-010000-00-00NoNoCurrent
69423-875-53694230875531 TUBE in 1 CARTON (69423-875-53) / 150 g in 1 TUBE1 tube2022-01-01NoNoCurrent