FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W8T17847WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198342Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59afcfbe-fe04-49c9-b1c5-28f2c4311c01Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Urea Cream 40 PercentUREABryant Ranch Prepack59afcfbe-fe04-49c9-b1c5-28f2c4311c012025-11-12Warnings, Adverse reactionsExact identifier
ndc (product): 71335-2868

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 g2025-11-12NoNoCurrent