FDA.reportPublic FDA data

Urea Cream 40 Percent

Product NDC
72162-2203
11-digit product format
721622203
Labeler code
72162
Product ID
72162-2203_47c029cd-a0dc-45a7-a91f-729889bcf007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-31
Substance
UREA
Active strength
400 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
Urea Cream 40 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2203-4Urea Cream 40 Percent85 g in 1 BOTTLECREAM85101
72162-2203-7Urea Cream 40 Percent28.35 g in 1 BOTTLECREAM28.35101
72162-2203-8Urea Cream 40 Percent198.4 g in 1 BOTTLECREAM198.4101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2203UREA CREAM 40 PERCENT (UREA) CREAM [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20231227_e28969bc-c3a0-49e5-9947-aee0c6b8b0b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 400 MG/ML Topical CreamSCDe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 40 % Topical CreamSYe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2203-47216222030485 g in 1 BOTTLE (72162-2203-4) 85 g2023-12-19NoNoCurrent
72162-2203-77216222030728.35 g in 1 BOTTLE (72162-2203-7) 28.35 g2023-12-19NoNoCurrent
72162-2203-872162220308198.4 g in 1 BOTTLE (72162-2203-8) 198.4 g2023-12-19NoNoCurrent