warnings
WARNING: KEEP OUT OF REACH OF CHILDREN.
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
- Brand name
- UREA
- Generic name
- UREA
- Manufacturer
- BioComp Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0fb373f8-5328-2f10-e063-6294a90a2484
- SPL ID
- 4846c3d5-f1ff-20dc-e063-6394a90a2a3d
- Version
- 2
- Effective date
- 2026-01-13
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:30:31
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | UREA | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | BioComp Pharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 44523-618-03 | openfda.package_ndc |
| ndc | product | 44523-618 | openfda.product_ndc |
| ndc11 | package | 44523061803 | derived:openfda.package_ndc |
| rxcui | 198886 | openfda.rxcui | |
| spl id | 4846c3d5-f1ff-20dc-e063-6394a90a2a3d | id | |
| spl set id | 0fb373f8-5328-2f10-e063-6294a90a2484 | set_id | |
| unii | 8W8T17847W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.