The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Urea 39% Cream
Urea 39% Cream · UREA 390 mg/g · Cream · Topical · BioComp Pharma, Inc.
NDC 44523-0801-08 · 227 g in 1 BOTTLE · UNAPPROVED DRUG OTHER · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Medicaid spend (2023)
$292,990
731 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for urea (other) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Mission Pharmacal CompanyUnited Statesmanufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- —
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- —
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Urea 39% Cream (Cream)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| BioComp Pharma, Inc. | UREA 390 mg/g | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Urea 39% Cream — NDC 44523-0801-08," retrieved September 3, 2026, https://drugdashboards.com/drug/44523080108.
Free to cite with attribution — see how the data is put together.