UREVEX
- Product NDC
- 85622-605
- 11-digit product format
- 856220605
- Labeler code
- 85622
- Product ID
- 85622-605_89018c92-8004-4cd5-b111-71b86b393730
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Blue Heron Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-04-28
- Substance
- UREA
- Active strength
- 200 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|
| UREVEX | UREA | Blue Heron Pharmaceuticals, LLC | 1ed71529-7607-47ff-bd16-3c9a63e1c733 | 2026-04-28 | Warnings, Adverse reactions | Exact identifier |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNING: KEEP OUT OF REACH OF CHILDREN.
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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UREVEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 200 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 198886 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85622-605-03 | UREVEX | 85 g in 1 BOTTLE, PLASTIC | CREAM | 85 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 85622-605-03 | 85622060503 | 85 g in 1 BOTTLE, PLASTIC | 85 g | Historical |