DrugDashboards

Defensolito

Acetaminophen, Phenylephrine Hydrochloride · ACETAMINOPHEN 80 mg/1; PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/1 · Tablet, Chewable · Oral · Menper Distributors, Inc.

NDC 53145-0006-02 · 50 PACKET in 1 CARTON / 2 TABLET, CHEWABLE in 1 PACKET · 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 acetaminophen, phenylephrine hydrochloride (oral solid) in the next 90 days

sole-source market · price up 2% YoY

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 →

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, Phenylephrine Hydrochloride (Tablet, Chewable)

LabelerStrengthFirst seenLast seen
Menper Distributors, Inc.ACETAMINOPHEN 80 mg/1; PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/1Jul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Defensolito — NDC 53145-0006-02," retrieved September 3, 2026, https://drugdashboards.com/drug/53145000602.

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