Urea 10%
- Product NDC
- 87021-600
- 11-digit product format
- 870210600
- Labeler code
- 87021
- Product ID
- 87021-600_5fc45306-8c85-47ac-b3a6-07c3ea29d829
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Urea 10%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Krewe Pharma, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-06-02
- Substance
- UREA
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Urea 10%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 100 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87021-600-04 | 87021060004 | 1 JAR in 1 JAR (87021-600-04) / 118 mL in 1 JAR | 1 jar | 2026-10-22 | No | No | Current |