COLTALIN-DM

Product NDC

51467-007

Requested package NDC

51467-007-01

11-digit product format

514670007

Labeler code

51467

Product ID

51467-007_5ba0ac3f-3a30-ff16-e063-6294a90ae04a

Type

HUMAN OTC DRUG

Nonproprietary name

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Labeler

FORTUNE PHARMACAL COMPANY LIMITED

Application

M012

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2025-07-01

Marketing end

2029-06-30

Substance

ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

Active strength

325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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

Current FDA listing

Yes