FDA.reportPublic FDA data

Mucus Relief DM Max

Product NDC
63868-235
11-digit product format
638680235
Labeler code
63868
Product ID
63868-235_600dbf7e-2378-4357-b0a8-d6928a66695a
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-03-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-235DDiscontinued by firm2026-10-05
excluded packagepackage63868-23563868-235-06DDiscontinued 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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-235-06Mucus Relief DM MaxMaximum Strength177 mL in 1 BOTTLE, PLASTICLIQUID1774

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-235-06ML - Milliliter63868-235cb4bb3a6-7b4e-45c5-9eb4-c33326cf696512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-235MUCUS RELIEF DM MAX MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC, 1 package rows20240502_d56c80b9-1073-4bf6-bc4b-9d5e14c99f8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNd56c80b9-1073-4bf6-bc4b-9d5e14c99f8e4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd56c80b9-1073-4bf6-bc4b-9d5e14c99f8e4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYd56c80b9-1073-4bf6-bc4b-9d5e14c99f8e4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd56c80b9-1073-4bf6-bc4b-9d5e14c99f8e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-235-0663868023506177 mL in 1 BOTTLE, PLASTIC (63868-235-06) 177 ml2016-03-310000-00-00NoNoCurrent