The short version
13 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Urea Cream 40%
Urea · UREA 400 mg/g · Cream · Topical · Laser Pharmaceuticals, LLC
NDC 16477-0340-01 · 1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC · 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
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 →
Regulatory
- Application
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- TE code
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- Approval date
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- Patents / exclusivity
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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 (Cream)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bryant Ranch Prepack | UREA 400 mg/g | Jul 15, 2026 | Sep 3, 2026 |
| Method Pharmaceuticals, LLC | UREA 400 mg/g | Jul 15, 2026 | Sep 3, 2026 |
| Akron Pharma Inc. | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | UREA 40 g/100g | Jul 15, 2026 | Sep 2, 2026 |
| BioComp Pharma, Inc. | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| BioComp Pharma, Inc. | UREA 200 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Blue Heron Pharmaceuticals, LLC | UREA 200 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | UREA 39 g/100g | Jul 15, 2026 | Sep 2, 2026 |
| Cintex Services, LLC | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Krewe Pharma, LLC | UREA 390 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Krewe Pharma, LLC | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Laser Pharmaceuticals, LLC | UREA 410 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Laser Pharmaceuticals, LLC | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Oncora Pharma, LLC | UREA 410 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Patrin Pharma, Inc | UREA 400 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| PureTek Corporation | UREA 410 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| PureTek Corporation | UREA 395 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Shengnan (Guangzhou) Cosmetics Co., LTD | (HYDROXYMETHYL)UREA 100 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Urea Cream 40% — NDC 16477-0340-01," retrieved September 3, 2026, https://drugdashboards.com/drug/16477034001.
Free to cite with attribution — see how the data is put together.