FDA.reportPublic FDA data

Cough and Cold HBP

Product NDC
63868-179
11-digit product format
638680179
Labeler code
63868
Product ID
63868-179_62e78ce3-58e7-43da-b4e4-a2acb073024f
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-03-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-179DDiscontinued by firm2026-10-05
excluded packagepackage63868-17963868-179-01DDiscontinued by firm2026-10-05
excluded packagepackage63868-17963868-179-16DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
63868-179-01Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED811
63868-179-01Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED211
63868-179-16Cough and Cold HBP3 in 1 CARTONTABLET, FILM COATED311
63868-179-16Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-179-01EA - Each63868-179ddafb0f3-b5b8-4600-9ac3-cd38c854fb7612018-03-08
63868-179-16EA - Each63868-17981cd7b50-3eda-4121-acf8-d362e792d16612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-179COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]11Legacy NDC, 4 package rows20240921_320152b8-17ef-40c0-8e4b-cd8f846ae6f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN320152b8-17ef-40c0-8e4b-cd8f846ae6f511
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD320152b8-17ef-40c0-8e4b-cd8f846ae6f511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-179-01638680179012 BLISTER PACK in 1 CARTON (63868-179-01) > 8 TABLET, COATED in 1 BLISTER PACK2 blister pack2017-03-310000-00-00NoNoCurrent
63868-179-16638680179163 BLISTER PACK in 1 CARTON (63868-179-16) > 8 TABLET, COATED in 1 BLISTER PACK3 blister pack2017-03-310000-00-00NoNoCurrent