The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Acetaminophen and Diphenhydramine HCL
Acetaminophen and Diphenhydramine HCL · ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE 25 mg/1 · Tablet · Oral · Safeway
NDC 21130-0661-10 · 100 TABLET in 1 BOTTLE · 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.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for acetaminophen, diphenhydramine hcl (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
- M013
- 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 HCL (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Publix Supermarkets, Inc | DIPHENHYDRAMINE 25 mg/1; ACETAMINOPHEN 500 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Safeway | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Publix Supermarkets, Inc | DIPHENHYDRAMINE 500 mg/1; ACETAMINOPHEN 25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Publix Supermarkets, Inc | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE 25 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Acetaminophen and Diphenhydramine HCL — NDC 21130-0661-10," retrieved September 3, 2026, https://drugdashboards.com/drug/21130066110.
Free to cite with attribution — see how the data is put together.