DrugDashboards

Diphenhydramine Hcl 12.5 Mg Per 5 Ml

Diphenhydramine Hcl 12.5 Mg Per 5 Ml · DIPHENHYDRAMINE 12.5 mg/5mL · Solution · Oral · Aarna Usa Inc.

NDC 82568-0016-08 · 236 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. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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

$0$0.01$0.02Dec 2025Sep 2026$0.016
10 price points · per MLSource: CMS NADAC

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.0%chance of a new FDA shortage posting for diphenhydramine hcl 12.5 mg per 5 ml (other) in the next 90 days

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 →

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 Diphenhydramine Hcl 12.5 Mg Per 5 Ml (Solution)

LabelerStrengthFirst seenLast seen
Aarna Usa Inc.DIPHENHYDRAMINE 12.5 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Diphenhydramine Hcl 12.5 Mg Per 5 Ml — NDC 82568-0016-08," retrieved September 3, 2026, https://drugdashboards.com/drug/82568001608.

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