Home NDC 85622-601 UREDEX
Product NDC 85622-601
11-digit product format 856220601
Labeler code 85622
Product ID 85622-601_08af3450-45c1-4a9c-ba34-b2db7d605f5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name UREA
Dosage form CREAM
Route TOPICAL
Labeler Blue Heron Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-01-07
Substance UREA
Active strength 200 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 UREDEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UREA 200 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 198886 Internal RxNorm 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 85622-601-03 UREDEX 85 g in 1 BOTTLE, PLASTIC CREAM 85 2
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UREDEX UREA Blue Heron Pharmaceuticals, LLC 0e4d7b03-527f-4cff-9154-7e5e485a8f80 2026-07-13 Warnings, Adverse reactions Exact identifier ndc (product): 85622-601
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85622-601-03 85622060103 85 g in 1 BOTTLE, PLASTIC (85622-601-03) 85 g 2026-01-07 No No Current