Urea 39% Cream
- Product NDC
- 44523-801
- 11-digit product format
- 445230801
- Labeler code
- 44523
- Product ID
- 44523-801_4846ec49-3653-db3d-e063-6294a90aa815
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea 39% Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- BioComp Pharma, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-09-23
- Substance
- UREA
- Active strength
- 390 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.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
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
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
- Urea 39% Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 390 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 1093289 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44523-801-08 | Urea 39% Cream | 227 g in 1 BOTTLE | CREAM | 227 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44523-801 | UREA 39% CREAM CREAM [BIOCOMP PHARMA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240308_e79004b9-ffbc-3d06-e053-2995a90a8cd7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44523-801-08 | 44523080108 | 227 g in 1 BOTTLE (44523-801-08) | 227 g | 2022-09-23 | 0000-00-00 | No | No | Current |