COLD AND FLU SEVERE

NDC 36800-502 · TOPCARE

Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

Dosage formTABLET, 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

36800-502-05 — 2 BLISTER PACK in 1 CARTON (36800-502-05) / 12 TABLET, COATED in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

36800-391 — Acetaminophen, Caffeine, Pyrilamine maleate, 36800-449 — Acetaminophen, 36800-450 — Acetaminophen, 36800-455 — Acetaminophen, 36800-459 — Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, 36800-466 — Acetaminophen, Diphenhydramine HCl, 36800-474 — ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE, 36800-484 — Acetaminophen, 36800-494 — dextromethorphan polistirex, 36800-499 — mineral oil, petrolatum, phenylephrine HCl, 36800-505 — ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE, 36800-509 — Dextromethorphan HBr, 36800-514 — ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE, 36800-521 — ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE, 36800-522 — acetaminophen, dextromethorphan Hbr, Phenylephrine HCl, 36800-533 — Acetaminophen, Aspirin, Caffeine, 36800-552 — dextromethorphan polistirex, 36800-556 — Acetaminophen, Diphenhydramine HCl, 36800-575 — ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE, 36800-581 — acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, +5267 more

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