Urea Cream 40 Percent

Product NDC
71335-2868
11-digit product format
713352868
Labeler code
71335
Product ID
71335-2868_8e9975a5-a55e-4037-89b8-8aa5c691fead
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Urea Cream 40 Percent
Listing expiration
2026-12-31

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
71335-2868-1Urea Cream 40 Percent28.35 g in 1 BOTTLECREAM28.35100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2868-1GM - Gram71335-286828c8cd5d-8c0e-4da0-9ee6-978d94bdfd4612026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN59afcfbe-fe04-49c9-b1c5-28f2c4311c01100
198342urea 400 MG/ML Topical CreamSCD59afcfbe-fe04-49c9-b1c5-28f2c4311c01100
198342urea 40 % Topical CreamSY59afcfbe-fe04-49c9-b1c5-28f2c4311c01100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2868-17133528680128.35 g in 1 BOTTLE (71335-2868-1) 28.35 g2025-11-12NoNoHistorical