Urea 20%
- Product NDC
- 59088-258
- Requested package NDC
- 59088-258-16
- 11-digit product format
- 590880258
- Labeler code
- 59088
- Product ID
- 59088-258_5c056c78-a173-af79-e063-6394a90aa654
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea 20%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PureTek Corporation
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-10-06
- Substance
- UREA
- Active strength
- 200 mg/g
- 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 20%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 200 mg/g |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 8W8T17847W | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 198886 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59088-258-16 | 59088025816 | 227 g in 1 JAR (59088-258-16) | 227 g | 2026-10-06 | No | No | Current |