DrugDashboards

Sinus and Headache

Acetaminophen and Phenylephrine HCl · ACETAMINOPHEN 325 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 · Tablet, Film Coated · Oral · Cardinal Health 110, LLC. DBA Leader

NDC 70000-0568-01 · 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK · OTC MONOGRAPH DRUG · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $0.0851 per unit over the past year. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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$0.05$0.1Mar 2021Sep 2026$0.0851
64 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$2.55
#90 count
$7.66

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

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10

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, phenylephrine hcl (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 and Phenylephrine HCl (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Cardinal Health 110, LLC. DBA LeaderACETAMINOPHEN 325 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
CVS PharmacyACETAMINOPHEN 325 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
United Natural Foods, Inc. dba UNFIACETAMINOPHEN 325 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Sinus and Headache — NDC 70000-0568-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70000056801.

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