DrugDashboards

Nighttime Sleep Aid

Diphenhydramine Hydrochloride · DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 · Tablet · Oral · Chain Drug Marketing Association, Inc.

NDC 83324-0110-32 · 4 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK · OTC MONOGRAPH DRUG · View full market →

The short version

31 companies list this market (plus 2 repackagers, which add no supply) — deep enough that no single failure threatens the supply. The price has held steady around $0.0603 per unit over the past year. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
  • CMS NADAC — latest price vs the price in effect ~12 months earlier
  • FDA drug shortages and enforcement reports (openFDA)
  • FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model
Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

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

ⓘ How this was built
Data sources
  • CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
  • CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
  • CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)
Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

$0$0.025$0.05$0.075Dec 2024Sep 2026$0.0603
21 price points · per EASource: CMS NADAC — monthly means to Nov 2024, weekly file after

Estimated fill cost

#30 count
$1.81
#90 count
$5.43

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Supply fragility

0Low risk

Nothing here is signaling trouble: several labelers (repackagers excluded), no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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 4, 2026

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers excluded via DailyMed SPL roles
  • FDA drug shortages and enforcement reports (openFDA)
  • CMS NADAC weekly file — price now vs the price in effect a year ago
Method

Fragility v1 adds fixed points per condition for this NDC's molecule × dosage form: active labelers minus repackagers (1 → +30, 2 → +20, 3 → +10, 4–5 → +5; unknown count → 0); shortage (this NDC listed Current +25, another presentation of the same molecule/form +15, a resolution within 12 months +8); Class I/II recalls in 12 months (this NDC +15, same molecule/form +8); NADAC down 40%+ year over year +15 or 20%+ +8 (a Medicare-negotiated price cut also trips this); sterile injectable form or intravenous route +10; a to-be-discontinued FDA listing +10; capped at 100. Every point shows as a line above. To check: count the molecule's labelers in the NDC Directory, then look it up in FDA's shortage list, openFDA enforcement, and two NADAC files a year apart.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for diphenhydramine hydrochloride (oral solid) in the next 90 days

price up 4% YoY

For scale: the typical drug’s chance is about 0.1% — this one is less than 1.5× that, which we treat as ordinary.

Backtested statistical model over the whole market, not this package alone. Model details →

ⓘ How this was built
Data sources
  • FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)
Method

A logistic regression over molecule × dosage-form markets, trained on a monthly grid of historical dates since 2019 with labels equal to whether a new FDA shortage posting appeared within the following 90 days; eight features knowable on each date (labeler count, sole-source flag, NADAC year-over-year change, Class I/II recalls, injectable form, discontinuation filings, open shortage episodes, recent OAI inspection). The probability shown is the model's output for today's feature values; the reasons are the features pushing this market's probability up, listed only when the feature actually holds here. Held-out performance and coefficients are on the fragility page.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Regulatory

Application
M010
TE code
Approval date
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application M010, edition retrieved 2026-08-24
Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Shortage history

ⓘ How this was built
Data sources
  • FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
  • Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
  • DrugDashboards Kaplan–Meier duration curves and conditional duration model
Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Not on FDA's current shortage list. Archived episodes below.

Archived episodes (FDA list history via Wayback, 2019+)
  • Planned discontinuation — Pfizer Pharmaceuticals, 50 mg/mL Carpuject™ Luer Lock Glass Syringe (NDC 00409-2290-31) (listed as “Diphenhydramine Hydrochloride Injection, USP”)Dec 28, 2020 → last seen Nov 30, 2021

Recalls (this NDC)

ⓘ How this was built
Data sources
  • FDA drug enforcement reports via openFDA
Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No enforcement reports list this package NDC.

Labelers of Diphenhydramine Hydrochloride (Tablet)

31 labelers active in the last 30 days, of which 2 are repackagers; 2not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
  • DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)
Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

LabelerStrengthsFirst seenLast seen
Cabinet Health P.B.C.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Strive Pharmaceuticals Inc.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Advance Pharmaceutical Inc.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Aldi IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Amazon.com Services LLCDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
American Sales CompanyDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Bell Pharmaceuticals, Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Bi-MartDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
BjwcDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Cabinet Health, IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCrepackagerDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Aug 26, 2026Sep 2, 2026
Chain Drug Marketing AssociationDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Chain Drug Marketing Association, Inc.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Discount Drug MartDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Dolgencorp IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Haendel Farma, S.A. de C.V.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Harris TeeterDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Health Pharma USA LLCDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
HebDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
L. Perrigo CompanyDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Precision Dose, Inc.repackagerDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Publix Super Markets IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Sam's West IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Simpex Pharma Pvt. LtdDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Twin Med LlcDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Valu Merchandisers CompanyDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Velocity Pharma LLCDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Vivunt Pharma LlcDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Walmart Inc.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
CVS PharmacyDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Aug 28, 2026
Meijer, Inc.DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Aug 28, 2026
Amerisource BergenDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Aug 5, 2026
Meijer Distribution IncDIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Aug 5, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Nighttime Sleep Aid — NDC 83324-0110-32," retrieved September 4, 2026, https://drugdashboards.com/drug/83324011032.

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