Severe Cold and Flu

NDC 70000-0525 · Cardinal Health 110, LLC. DBA Leader

Generic nameAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Strength325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1

Pharmacologic classAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]

Marketing categoryOTC MONOGRAPH DRUG

Packages

70000-0525-1 — 2 BLISTER PACK in 1 CARTON (70000-0525-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

70000-0410 — Acetaminophen, 70000-0411 — Acetaminophen, Diphenhydramine Hydrochloride, 70000-0425 — Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum, 70000-0464 — Guaifenesin, Dextromethorphan HBr, 70000-0479 — Guaifenesin, 70000-0481 — Acetaminophen, 70000-0491 — Guaifenesin, Dextromethorphan HBr, 70000-0496 — Acetaminophen, 70000-0515 — ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL, 70000-0516 — ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE, 70000-0565 — Dextromethorphan HBr, Guaifenesin, 70000-0568 — Acetaminophen and Phenylephrine HCl, 70000-0596 — dextromethorphan hydrobromide, guaifenesin, 70000-0611 — acetaminophen, aspirin, caffeine, 70000-0622 — Acetaminophen and Ibuprofen, 70000-0623 — Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, 70000-0626 — Acetaminophen, 70000-0627 — Acetaminophen, 70000-0628 — Dextromethorphan HBr, Guaifenesin, 70000-0629 — Dextromethorphan HBr, guaifenesin, Phenylephrine HCl, +5267 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