TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, And Phenylephrine Hydrochloride · Kit · Kenvue Brands LLC

NDC 50580-0231-01 · 1 KIT in 1 PACKAGE * 240 mL in 1 BOTTLE, PLASTIC * 240 mL in 1 BOTTLE, PLASTIC · OTC MONOGRAPH DRUG · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately.

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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, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, And Phenylephrine Hydrochloride (Kit)

Labeler	Strength	First seen	Last seen
Reckitt Benckiser LLC		Jul 15, 2026	Sep 2, 2026
Kenvue Brands LLC		Jul 15, 2026	Aug 31, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack — NDC 50580-0231-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50580023101.

Free to cite with attribution — see how the data is put together.