Evara

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: Evara
Generic name: UREA 40.5 CREAM
Manufacturer: Oncora Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 098d85ca-7f48-45a1-80ed-4d57936842b9
SPL ID: 3fc2bb16-70ef-41f8-9a6a-a6a42bf58e5f
Version: 2
Effective date: 2026-05-01
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:31

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		Evara	openfda.brand_name
generic name		UREA 40.5 CREAM	openfda.generic_name
manufacturer name		Oncora Pharma, LLC	openfda.manufacturer_name
ndc	package	85477-308-08	openfda.package_ndc
ndc	product	85477-308	openfda.product_ndc
ndc11	package	85477030808	derived:openfda.package_ndc
rxcui		2741686	openfda.rxcui
spl id		3fc2bb16-70ef-41f8-9a6a-a6a42bf58e5f	id
spl set id		098d85ca-7f48-45a1-80ed-4d57936842b9	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.

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