Urea 41%

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Urea 41%
Generic name: UREA
Manufacturer: Oncora Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 37576876-738c-ac79-e063-6394a90a84fe
SPL ID: 37576876-738d-ac79-e063-6394a90a84fe
Version: 1
Effective date: 2025-06-11
Source export date: 2026-08-08
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run: 20260810T161303Z
Imported at: 2026-08-10 17:31:14

Harmonized routes table
Harmonized routes
TOPICAL

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Urea 41%	openfda.brand_name
generic name		UREA	openfda.generic_name
manufacturer name		Oncora Pharma, LLC	openfda.manufacturer_name
ndc	package	85477-905-30	openfda.package_ndc
ndc	product	85477-905	openfda.product_ndc
ndc11	package	85477090530	derived:openfda.package_ndc
rxcui		1436933	openfda.rxcui
spl id		37576876-738d-ac79-e063-6394a90a84fe	id
spl set id		37576876-738c-ac79-e063-6394a90a84fe	set_id
unii		8W8T17847W	openfda.unii

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

WARNINGS Avoid contact with eyes, lips and mucous membranes.

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

ADVERSE REACTIONS: Discontinue use and consult a physician if redness or irritation occurs.