UREA

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
Generic name: UREA
Manufacturer: Bantry Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4
SPL ID: 36c18d8c-6e56-ad83-e063-6294a90a25fc
Version: 3
Effective date: 2025-06-04
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:54:10

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	openfda.brand_name
generic name		UREA	openfda.generic_name
manufacturer name		Bantry Pharma, LLC	openfda.manufacturer_name
ndc	package	81542-201-08	openfda.package_ndc
ndc	product	81542-201	openfda.product_ndc
ndc11	package	81542020108	derived:openfda.package_ndc
rxcui		351155	openfda.rxcui
spl id		36c18d8c-6e56-ad83-e063-6294a90a25fc	id
spl set id		cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4	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: KEEP OUT OF REACH OF CHILDREN.

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: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

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