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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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