UREA
- Product NDC
- 81542-201
- 11-digit product format
- 815420201
- Labeler code
- 81542
- Product ID
- 81542-201_36c18d8c-6e56-ad83-e063-6294a90a25fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bantry Pharma, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2021-09-07
- Substance
- UREA
- Active strength
- 400 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 |
|---|
| UREA | UREA | Bantry Pharma, LLC | cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4 | 2025-06-04 | Warnings, Adverse reactions | Exact identifier |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
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
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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 400 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 351155 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81542-201-08 | UREA | 226.8 g in 1 BOTTLE | LOTION | 226.8 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81542-201 | UREA LOTION [BANTRY PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230907_cb6ddbfc-ea6a-0ddc-e053-2995a90aedc4.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 |
|---|
| 81542-201-08 | 81542020108 | 226.8 g in 1 BOTTLE (81542-201-08) | 226.8 g | 2021-09-07 | 0000-00-00 | No | No | Current |