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Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime

acetaminophen and diphenhydramine hydrochloride · ACETAMINOPHEN 650 mg/20mL; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL · Solution · Oral · Haleon US Holdings LLC

NDC 00031-8770-12 · 1 BOTTLE in 1 CARTON / 118 mL 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.

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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
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 diphenhydramine hydrochloride (Solution)

LabelerStrengthFirst seenLast seen
Haleon US Holdings LLCACETAMINOPHEN 650 mg/20mL; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime — NDC 00031-8770-12," retrieved September 3, 2026, https://drugdashboards.com/drug/00031877012.

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