Cough and Cold HBP

Product NDC: 68016-049
Requested package NDC: 68016-049-16
11-digit product format: 680160049
Labeler code: 68016
Product ID: 68016-049_2cce92f8-7116-487e-a874-718f072381d1
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Chain Drug Consortium
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-05-15
Marketing end: 0000-00-00
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 4 mg/1; mg/1
Pharmacologic classes: 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]
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	68016-049	68016-049-16	D	Discontinued by firm		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-049-16	Cough and Cold HBP	8 in 1 BLISTER PACK	TABLET, FILM COATED	8		9
68016-049-16	Cough and Cold HBP	2 in 1 CARTON	TABLET, FILM COATED	2		9

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-049	COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]	8	Legacy NDC, 2 package rows	20240719_2aaaaef7-5dee-4f2d-97b4-772e99e1824b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-049-16	68016004916	2 BLISTER PACK in 1 CARTON (68016-049-16) > 8 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2017-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value 44-689 Delisted	Chain Drug Consortium \| LNK International, Inc.	2025-07-19	HUMAN OTC DRUG LABEL	9