The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Childrens Sudafed PE NASAL DECONGESTANT
Phenylephrine hydrochloride · PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL · Solution · Oral · Kenvue Brands LLC
NDC 50580-0784-04 · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE · OTC MONOGRAPH DRUG · View full market →
Medicare Part D
Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.
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.
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 phenylephrine hydrochloride (other) in the next 90 days
OAI inspection at a producing facility (24 months) · 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
- M012
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Phenylephrine hydrochloride (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Kenvue Brands LLC | PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Leading Pharma, LLC | PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Leading Pharma, LLC | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Somerset Therapeutics, LLC | PHENYLEPHRINE HYDROCHLORIDE .1 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, "Childrens Sudafed PE NASAL DECONGESTANT — NDC 50580-0784-04," retrieved September 3, 2026, https://drugdashboards.com/drug/50580078404.
Free to cite with attribution — see how the data is put together.