DrugDashboards

Duraflu

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl · PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1; ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; GUAIFENESIN 200 mg/1 · Tablet · Oral · Poly Pharmaceuticals, Inc.

NDC 50991-0535-01 · 100 TABLET in 1 BOTTLE · OTC MONOGRAPH DRUG · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $0.9041 per unit over the past year. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

$0$0.5$1.00May 2016Oct 2025$0.9041
23 price points · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

#30 count
$27.12
#90 count
$81.37

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$5,843
298 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for acetaminophen, guaifenesin, pseudoephedrine hcl, dextromethorphan hbr (oral solid) in the next 90 days

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 →

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 HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl (Tablet)

LabelerStrengthFirst seenLast seen
Poly Pharmaceuticals, Inc.PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1; ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; GUAIFENESIN 200 mg/1Aug 26, 2026Sep 2, 2026
Poly Pharmaceuticals, Inc.PSEUDOEPHEDRINE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 20 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 200 mg/1; GUAIFENESIN 60 mg/1Jul 22, 2026Aug 19, 2026
Poly Pharmaceuticals, Inc.ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1; GUAIFENESIN 200 mg/1; PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Duraflu — NDC 50991-0535-01," retrieved September 3, 2026, https://drugdashboards.com/drug/50991053501.

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