Urea
- Product NDC
- 51862-181
- 11-digit product format
- 518620181
- Labeler code
- 51862
- Product ID
- 51862-181_16eb680b-fd40-44fd-a115-41a868e7f03e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mayne Pharma Inc.
- Marketing category
- UNAPPROVED DRUG
- Marketing start
- 2011-10-28
- Marketing end
- 2019-03-31
- Substance
- UREA
- Active strength
- 450 mg/g
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 51862-181 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 51862-181 | 51862-181-28 | D | Discontinued by firm | | 2026-07-31 |