Urea Cream 40%
- Product NDC
- 71399-8456
- 11-digit product format
- 713998456
- Labeler code
- 71399
- Product ID
- 71399-8456_6153c0bc-1246-4396-a26d-cd066b909ef5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Akron Pharma Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2024-09-13
- Substance
- UREA
- Active strength
- 400 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Urea Cream 40%
- 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 | 198342 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71399-8456-1 | Urea Cream 40% | 28.35 g in 1 BOTTLE | CREAM | 28.35 | | 3 |
| 71399-8456-3 | Urea Cream 40% | 85 g in 1 BOTTLE | CREAM | 85 | | 3 |
| 71399-8456-7 | Urea Cream 40% | 198.45 g in 1 BOTTLE | CREAM | 198.45 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71399-8456 | UREA CREAM 40% (UREA) CREAM [AKRON PHARMA INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240927_0ce643e9-cf13-4b51-8ffd-8d5636d73e51.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 |
|---|
| 71399-8456-1 | 71399845601 | 28.35 g in 1 BOTTLE (71399-8456-1) | 28.35 g | 2024-09-13 | 0000-00-00 | No | No | Current |
| 71399-8456-3 | 71399845603 | 85 g in 1 BOTTLE (71399-8456-3) | 85 g | 2024-09-13 | 0000-00-00 | No | No | Current |
| 71399-8456-7 | 71399845607 | 198.45 g in 1 BOTTLE (71399-8456-7) | 198.45 g | 2024-09-13 | 0000-00-00 | No | No | Current |