Cough and Cold HBP

Product NDC
68016-049
11-digit product format
680160049
Labeler code
68016
Product ID
68016-049_50465f8a-2923-441c-9e95-1ddcadb0468e
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-15
Marketing end
2026-05-31
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4; 30 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
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-049-16Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED89
68016-049-16Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-049COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]8Current NDC, Legacy NDC, 2 package rows20240719_2aaaaef7-5dee-4f2d-97b4-772e99e1824b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-049-16680160049162 BLISTER PACK in 1 CARTON (68016-049-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2017-05-152026-05-31NoNoCurrent