Home NDC 85622-603 Urevia Plus
Product NDC 85622-603
11-digit product format 856220603
Labeler code 85622
Product ID 85622-603_ca2df984-73e5-4539-a463-3a1ffc0cafb0
Type HUMAN OTC DRUG
Nonproprietary name Urea 40%
Dosage form CREAM
Route TOPICAL
Labeler Blue Heron Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-06-04
Substance UREA
Active strength 400 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Urevia Plus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UREA 400 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198342 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 85622-603-04 85622060304 1 JAR in 1 JAR (85622-603-04) / 113 g in 1 JAR 1 jar 2026-06-04 No No Current