The short version
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Acetaminophen and Diphenhydramine citrate
Acetaminophen and Diphenhydramine citrate · ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE CITRATE 38 mg/1 · Tablet · Oral · InvaTech Pharma Solutions LLC
NDC 57631-0010-00 · 30000 TABLET in 1 BOX · OTC MONOGRAPH DRUG · View full market →
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 citrate (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| InvaTech Pharma Solutions LLC | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE CITRATE 38 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Acetaminophen and Diphenhydramine citrate — NDC 57631-0010-00," retrieved September 3, 2026, https://drugdashboards.com/drug/57631001000.
Free to cite with attribution — see how the data is put together.