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SUDAFED PE Head Congestion Plus Flu Severe

NDC 50580-450 · Kenvue Brands LLC

Generic nameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage formTABLET, FILM COATED
RouteORAL
Active ingredient(s)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Strength325; 10; 100; 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

50580-450-01 — 2 BLISTER PACK in 1 CARTON (50580-450-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

50580-403 — Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride, 50580-415 — Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride, 50580-424 — ACETAMINOPHEN, 50580-433 — Acetaminophen, 50580-435 — Acetaminophen and Phenylephrine hydrochloride, 50580-436 — Ibuprofen and Phenylephrine Hydrochloride, 50580-437 — Phenylephrine Hydrochloride, 50580-446 — Acetaminophen and Dextromethorphan Hydrobromide, 50580-447 — acetaminophen, guaifenesin, and phenylephrine hydrochloride, 50580-449 — Acetaminophen, 50580-451 — Acetaminophen, 50580-456 — Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride, 50580-457 — acetaminophen, 50580-458 — acetaminophen, 50580-469 — Acetaminophen, 50580-472 — Acetaminophen, 50580-475 — Acetaminophen, 50580-488 — Acetaminophen, 50580-490 — Acetaminophen, 50580-491 — acetaminophen, +5267 more

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