Urea 20
- Product NDC
- 50268-820
- 11-digit product format
- 502680820
- Labeler code
- 50268
- Product ID
- 50268-820_48379414-bcb9-1797-e063-6394a90aa8fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Urea
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- AvPAK
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-09-19
- 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.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS SECTION Caution: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Urea 20
- 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-820-85 | Urea 20 | 1 in 1 CARTON | GEL | 1 | | 4 |
| 50268-820-85 | Urea 20 | 85 g in 1 TUBE | GEL | 85 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-820 | UREA 20 (UREA) GEL [AVPAK] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240308_e994fa05-a457-2555-e053-2a95a90ae83b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-820-85 | 50268082085 | 1 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBE | 1 tube | 2022-09-19 | 0000-00-00 | No | No | Current |