FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
69423-754
11-digit product format
694230754
Labeler code
69423
Product ID
69423-754_47e28597-136f-217d-e063-6294a90a2cec
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
2023-02-09
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 Pro-Health
Brand name suffix
Densify Active Repair
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-754-35Crest Pro-HealthDensify Active Repair1 in 1 CARTONPASTE, DENTIFRICE15
69423-754-35Crest Pro-HealthDensify Active Repair99 g in 1 TUBEPASTE, DENTIFRICE995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-754CREST PRO-HEALTH DENSIFY ACTIVE REPAIR (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, 2 package rows20250110_f4487d78-1da8-3f33-e053-2a95a90a6d92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf4487d78-1da8-3f33-e053-2a95a90a6d925
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf4487d78-1da8-3f33-e053-2a95a90a6d925
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf4487d78-1da8-3f33-e053-2a95a90a6d925
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf4487d78-1da8-3f33-e053-2a95a90a6d925
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf4487d78-1da8-3f33-e053-2a95a90a6d925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-754-35694230754351 TUBE in 1 CARTON (69423-754-35) / 99 g in 1 TUBE1 tube2023-02-09NoNoCurrent