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ACETAMINOPHEN and DIPHENHYDRAMINE CITRATE

ACETAMINOPHEN and DIPHENHYDRAMINE CITRATE · DIPHENHYDRAMINE CITRATE 38 mg/1; ACETAMINOPHEN 500 mg/1 · Tablet, Film Coated · Prodose, Inc.

NDC 68210-1012-00 · 1 BAG in 1 DRUM / 31000 TABLET, FILM COATED in 1 BAG · 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 and DIPHENHYDRAMINE CITRATE (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Prodose, Inc.DIPHENHYDRAMINE CITRATE 38 mg/1; ACETAMINOPHEN 500 mg/1Aug 20, 2026Sep 3, 2026
Prodose, Inc.DIPHENHYDRAMINE CITRATE 500 mg/1; ACETAMINOPHEN 38 mg/1Jul 22, 2026Aug 19, 2026
Prodose, Inc.ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE CITRATE 38 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "ACETAMINOPHEN and DIPHENHYDRAMINE CITRATE — NDC 68210-1012-00," retrieved September 3, 2026, https://drugdashboards.com/drug/68210101200.

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