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Severe cold and flu

NDC 49580-4160 · P & L Development, LLC

Generic nameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
Dosage formLIQUID
RouteORAL
Active ingredient(s)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Strength650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classAdrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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

49580-4160-8 — 237 mL in 1 BOTTLE, PLASTIC (49580-4160-8)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

49580-0415 — Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, 49580-0416 — Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI, 49580-0466 — Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, 49580-0501 — ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL, 49580-0502 — Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl, 49580-0685 — Acetaminophen, 49580-0821 — Acetaminophen, 49580-0834 — Dextromethorphan HBr Guaifenesin, 49580-2880 — Acetaminophen, 49580-3278 — Acetaminophen, 49873-082 — acetaminophen, 49873-108 — acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, 49873-109 — Chlorpheniramine maleate, phenylephrine, 49873-113 — acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, 49873-114 — acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, 49873-301 — dextromethorphan hydrobromide, 49873-302 — dextromethorphan hydrobromide, guaifenesin, 49873-306 — dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, 49884-186 — Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg, 49999-060 — ACETAMINOPHEN AND CODEINE PHOSPHATE, +4930 more

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