FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
70000-0565
11-digit product format
700000565
Labeler code
70000
Product ID
70000-0565_3cf5c25c-bdbf-4f5e-ab05-e445d4c83c59
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-04-30
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 productproduct70000-0565DDiscontinued by firm2026-10-05
excluded packagepackage70000-056570000-0565-1DDiscontinued 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
70000-0565-1Mucus Relief DMMaximum Strength177 mL in 1 BOTTLE, PLASTICLIQUID1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0565-1ML - Milliliter70000-05657d94614b-8b9d-459c-8329-2277297708a612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0565MUCUS RELIEF DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CARDINAL HEALTH (LEADER) 70000]5Legacy NDC, 1 package rows20241011_c4971d15-c768-4370-b7b3-f0b4848e1758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNc4971d15-c768-4370-b7b3-f0b4848e17587
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc4971d15-c768-4370-b7b3-f0b4848e17587
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYc4971d15-c768-4370-b7b3-f0b4848e17587
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc4971d15-c768-4370-b7b3-f0b4848e17587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0565-170000056501177 mL in 1 BOTTLE, PLASTIC (70000-0565-1) 177 ml2020-04-300000-00-00NoNoCurrent