warnings
WARNING: KEEP OUT OF REACH OF CHILDREN.
UREDEX
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
- UREDEX
- Generic name
- UREA
- Manufacturer
- Blue Heron Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0e4d7b03-527f-4cff-9154-7e5e485a8f80
- SPL ID
- 979c3a57-d848-4a91-bed7-517717396645
- Version
- 3
- Effective date
- 2026-07-13
- Source export date
- 2026-11-06
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:18:34
| 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 | UREDEX | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | Blue Heron Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 85622-601-03 | openfda.package_ndc |
| ndc | product | 85622-601 | openfda.product_ndc |
| ndc11 | package | 85622060103 | derived:openfda.package_ndc |
| rxcui | 198886 | openfda.rxcui | |
| spl id | 979c3a57-d848-4a91-bed7-517717396645 | id | |
| spl set id | 0e4d7b03-527f-4cff-9154-7e5e485a8f80 | 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.