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Acetaminophen 325 mg, Diphenhydramine HCL 12.5 mg, Phenylephrine HCl 5 mg

Acetaminophen 325 mg, Diphenhydramine HCL 12.5 mg, Phenylephrine HCl 5 mg · ACETAMINOPHEN 325 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 · Tablet, Film Coated · Shield Pharmaceuticals Corp

NDC 83059-0038-00 · 10000 TABLET, FILM COATED in 1 DRUM · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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
TE code
Approval date
Patents / exclusivity

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 325 mg, Diphenhydramine HCL 12.5 mg, Phenylephrine HCl 5 mg (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Shield Pharmaceuticals CorpACETAMINOPHEN 325 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Shield Pharmaceuticals CorpACETAMINOPHEN 325 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Acetaminophen 325 mg, Diphenhydramine HCL 12.5 mg, Phenylephrine HCl 5 mg — NDC 83059-0038-00," retrieved September 3, 2026, https://drugdashboards.com/drug/83059003800.

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