UREA
- Product NDC
- 71399-8455
- 11-digit product format
- 713998455
- Labeler code
- 71399
- Product ID
- 71399-8455_ce61c92f-c0eb-4f9b-9b7f-98cb72499e1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- AKRON PHARMA INC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2024-09-13
- Substance
- UREA
- Active strength
- 40 g/100g
- 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 | AKRON PHARMA INC | 3c0d612a-2247-448d-ae65-f9abfd894158 | 2024-09-25 | Warnings, Adverse reactions | Exact identifier |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
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 medication.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UREA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 40 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 351155 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71399-8455-8 | UREA | 227 g in 1 BOTTLE | LOTION | 227 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71399-8455 | UREA (UREA) LOTION [AKRON PHARMA INC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240927_3c0d612a-2247-448d-ae65-f9abfd894158.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 |
|---|
| 71399-8455-8 | 71399845508 | 227 g in 1 BOTTLE (71399-8455-8) | 227 g | 2024-09-13 | 0000-00-00 | No | No | Current |