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 41
Manufacturer: Oncora Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ff306984-a52b-48d8-88a8-3a4c72109e63
SPL ID: b128343f-a2d2-416d-b349-d5e39bdc3671
Version: 1
Effective date: 2026-03-06
Source export date: 2026-11-06
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:10:36

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Urea 41	openfda.brand_name
generic name		UREA 41	openfda.generic_name
manufacturer name		Oncora Pharma, LLC	openfda.manufacturer_name
ndc	package	85477-306-27	openfda.package_ndc
ndc	product	85477-306	openfda.product_ndc
ndc11	package	85477030627	derived:openfda.package_ndc
spl id		b128343f-a2d2-416d-b349-d5e39bdc3671	id
spl set id		ff306984-a52b-48d8-88a8-3a4c72109e63	set_id
unii		8W8T17847W	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS For external use only. Avoid contact with eyes, lips, or mucous membranes. Discontinue use and consult a physician if redness, irritation, or sensitivity occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.