Home NDC 85477-306-27 Urea 41
Product NDC 85477-306
Requested package NDC 85477-306-27
11-digit product format 854770306
Labeler code 85477
Product ID 85477-306_b128343f-a2d2-416d-b349-d5e39bdc3671
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Urea 41
Dosage form CREAM
Route TOPICAL
Labeler Oncora Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-03-06
Substance UREA
Active strength 41 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 41
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UREA 41 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8W8T17847W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85477-306-27 Urea 41 227 g in 1 JAR CREAM 227 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-306-27 85477030627 227 g in 1 JAR (85477-306-27) 227 g 2026-03-06 No No Current