DrugDashboards

Daytime Non-Drowsy Cold and Flu

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE · ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 · Capsule, Liquid Filled · Oral · Walgreens Company

NDC 00363-8998-16 · 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK · OTC MONOGRAPH DRUG · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble.

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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride (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 HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE (Capsule, Liquid Filled)

LabelerStrengthFirst seenLast seen
Raritan Pharmaceuticals Inc.ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 23, 2026Sep 3, 2026
Reckitt Benckiser LLCACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 3, 2026
Advanced Rx LLCACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Lil' Drug Store Products, Inc.ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Patheon Softgels IncACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
The Procter & Gamble Manufacturing CompanyACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
WalgreensACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Walgreens CompanyACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Lil' Drug Store Products, Inc.ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Daytime Non-Drowsy Cold and Flu — NDC 00363-8998-16," retrieved September 3, 2026, https://drugdashboards.com/drug/00363899816.

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