DrugDashboards

TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief

Acetaminophen, Lidocaine, Menthol · Kit · Kenvue Brands LLC

NDC 50580-0142-01 · 1 KIT in 1 KIT * 1 BOTTLE in 1 CARTON / 225 TABLET, COATED in 1 BOTTLE * 1 TUBE in 1 CARTON / 14.2 g in 1 TUBE · OTC MONOGRAPH DRUG · View full market →

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.

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
M013
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, Lidocaine, Menthol (Kit)

LabelerStrengthFirst seenLast seen
Kenvue Brands LLCJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief — NDC 50580-0142-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50580014201.

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