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Diphenhydramine HCl

NDC 0121-0865 · PAI Holdings, LLC dba PAI Pharma

Generic namediphenhydramine hydrochloride
Dosage formSOLUTION
RouteORAL
Active ingredient(s)DIPHENHYDRAMINE HYDROCHLORIDE
Strength12.5 mg/5mL
Pharmacologic classHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
Marketing categoryOTC MONOGRAPH DRUG

Packages

0121-0865-00 — 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)

0121-0865-30 — 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0067-8137 — acetaminophen, diphenhydramine HCl, phenylephrine HCl, 0067-8212 — ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl, 0113-0186 — Diphenhydramine HCl, 0113-0379 — Diphenhydramine HCl, 0113-0431 — Diphenhydramine Hydrochloride, 0113-0437 — Acetaminophen, Diphenhydramine HCl, 0113-0479 — Diphenhydramine Hydrochloride, 0113-0622 — Diphenhydramine Hydrochloride, Zinc Acetate, 0113-8264 — diphenhydramine hydrochloride, naproxen sodium, 0121-0489 — DIPHENHYDRAMINE HYDROCHLORIDE, 0121-0978 — DIPHENHYDRAMINE HYDROCHLORIDE, 0121-1730 — diphenhydramine hydrochloride, 0135-0608 — acetaminophen and diphenhydramine HCl, 0135-7021 — acetaminophen and diphenhydramine HCl, 0280-1200 — DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM, 0363-0058 — Diphenhydramine HCI, Phenylephrine HCl, 0363-0092 — Diphenhydramine Hydrochloride, 0363-0100 — DIPHENHYDRAMINE HYDROCHLORIDE, 0363-0189 — Diphenhydramine HCl, 0363-0207 — IBUPROFEN, DIPHENHYDRAMINE HCL, +1029 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels