Home NDC 44523-618 UREA
Product NDC 44523-618
11-digit product format 445230618
Labeler code 44523
Product ID 44523-618_4846c3d5-f1ff-20dc-e063-6394a90a2a3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name UREA
Dosage form CREAM
Route TOPICAL
Labeler BioComp Pharma, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-02-15
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 UREA
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 44523-618-03 UREA 85 g in 1 BOTTLE, PLASTIC CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-618 UREA CREAM [BIOCOMP PHARMA, INC.] 1 Current NDC, 1 package rows 20240215_0fb373f8-5328-2f10-e063-6294a90a2484.zip
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 UREA UREA BioComp Pharma, Inc. 0fb373f8-5328-2f10-e063-6294a90a2484 2026-01-13 Warnings, Adverse reactions Exact identifier ndc (product): 44523-618
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44523-618-03 44523061803 85 g in 1 BOTTLE, PLASTIC (44523-618-03) 85 g 2024-02-15 No No Current