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.
Sudafed Sinus Congestion Plus Cold Severe Day
Acetaminophen, Pseudoephedrine · PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1; ACETAMINOPHEN 500 mg/1 · Tablet, Film Coated · Oral · Kenvue Brands LLC
NDC 50580-0659-10 · 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK · 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.
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Opioid Analgesic REMS Shared System REMS
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 Acetaminophen, Pseudoephedrine (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Kenvue Brands LLC | PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1; ACETAMINOPHEN 500 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Kenvue Brands LLC | PSEUDOEPHEDRINE HYDROCHLORIDE 500 mg/1; ACETAMINOPHEN 30 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Kenvue Brands LLC | ACETAMINOPHEN 500 mg/1; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Sudafed Sinus Congestion Plus Cold Severe Day — NDC 50580-0659-10," retrieved September 3, 2026, https://drugdashboards.com/drug/50580065910.
Free to cite with attribution — see how the data is put together.