FDA.reportPublic FDA data

Urea 40 Percent

Product NDC
71335-2890
11-digit product format
713352890
Labeler code
71335
Product ID
71335-2890_4253879c-b155-dadb-e063-6394a90ad4fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-15
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 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
3d9bf300-cb72-463b-be9a-70c8d9a55b63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2890-1Urea 40 Percent198.4 g in 1 BOTTLECREAM198.4100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2890-1GM - Gram71335-2890b2d787a6-817f-4dd3-b12a-d686f596036f12026-01-08

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 40 PercentUREABryant Ranch Prepack3d9bf300-cb72-463b-be9a-70c8d9a55b632025-10-29Warnings, Adverse reactionsExact identifier
ndc (product): 71335-2890

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN3d9bf300-cb72-463b-be9a-70c8d9a55b63100
198342urea 400 MG/ML Topical CreamSCD3d9bf300-cb72-463b-be9a-70c8d9a55b63100
198342urea 40 % Topical CreamSY3d9bf300-cb72-463b-be9a-70c8d9a55b63100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2890-171335289001198.4 g in 1 BOTTLE (71335-2890-1) 198.4 g2025-10-29NoNoCurrent