Daytime Severe

Product NDC

59640-308

11-digit product format

596400308

Labeler code

59640

Product ID

59640-308_bc7cb237-0b43-4e30-a85e-5c635c831838

Type

HUMAN OTC DRUG

Nonproprietary name

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

H E B

Application

M012

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2025-08-05

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

Active strength

325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL

Pharmacologic classes

Adrenergic 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]

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes