Broncolito

Product NDC

55758-520

11-digit product format

557580520

Labeler code

55758

Product ID

55758-520_54ec4c3c-358a-2601-e063-6294a90afcf8

Type

HUMAN OTC DRUG

Nonproprietary name

Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

Dosage form

SYRUP

Route

ORAL

Labeler

Pharmadel LLC

Application

M012

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2026-07-01

Substance

GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Active strength

50; 2.5; 5 mg/2.5mL; mg/2.5mL; mg/2.5mL

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

2027-12-31

Current FDA listing

Yes