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
- 6774a5ef-9bb0-4e7a-e053-2a91aa0af47f
- SPL ID
- 4629c716-aa54-7dc4-e063-6294a90a3dec
- Version
- 6
- Effective date
- 2025-12-17
- Source export date
- 2026-10-30
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:58:50
| 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 | 44523-617-07 | openfda.package_ndc |
| ndc | package | 44523-617-03 | openfda.package_ndc |
| ndc | package | 44523-617-01 | openfda.package_ndc |
| ndc | product | 44523-617 | openfda.product_ndc |
| ndc11 | package | 44523061707 | derived:openfda.package_ndc |
| ndc11 | package | 44523061703 | derived:openfda.package_ndc |
| ndc11 | package | 44523061701 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 4629c716-aa54-7dc4-e063-6294a90a3dec | id | |
| spl set id | 6774a5ef-9bb0-4e7a-e053-2a91aa0af47f | 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.