BranTussin DM

Product NDC: 71321-700
Requested package NDC: 71321-700-16
11-digit product format: 713210700
Labeler code: 71321
Product ID: 71321-700_eaf11cdf-197e-b595-e053-2995a90a3784
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Brandywine Pharmaceuticals, LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-10-14
Marketing end: 0000-00-00
Substance: DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [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]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71321-700	71321-700-16	D	Discontinued by firm		2026-10-16

Adverse event summaries are temporarily unavailable. Other product information remains available.

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71321-700-16	ML - Milliliter	71321-700	97f688cd-a132-4f58-be08-787b3d9ed222	1	2022-12-07

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71321-700	BRANTUSSIN DM (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BRANDYWINE PHARMACEUTICALS, LLC]	2	Legacy NDC	20240110_eaf11ba7-b0e2-a422-e053-2995a90ae2a9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71321-700-16	71321070016	473 mL in 1 BOTTLE (71321-700-16)	473 ml	2022-10-14	0000-00-00	No	No	Current