FDA.reportPublic FDA data

Mucinex DM

Product NDC
52904-650
11-digit product format
529040650
Labeler code
52904
Product ID
52904-650_bdf888fe-0c3b-4255-86e6-1239139da2ba
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin and dextromethorphan hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Select Corporation
Application
NDA021620
Marketing category
NDA
Marketing start
2012-06-26
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30 mg/1; mg/1
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-650-032024-01-30C16284748780-11030e365-594c-111a-e063-dadaa90a10e2Mucinex® DM
52904-650-202024-01-30C16284748780-11030e365-594c-111a-e063-dadaa90a10e2Mucinex® DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-650-03Mucinex DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE11
52904-650-03Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE21
52904-650-20Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE21
52904-650-20Mucinex DM20 in 1 CARTONTABLET, EXTENDED RELEASE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-650MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [SELECT CORPORATION]1Legacy NDC, 4 package rows20220415_c818e103-9578-469c-97c0-d3515b934c03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNc818e103-9578-469c-97c0-d3515b934c031
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDc818e103-9578-469c-97c0-d3515b934c031
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYc818e103-9578-469c-97c0-d3515b934c031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-650-03529040650031 POUCH in 1 BLISTER PACK (52904-650-03) > 2 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2012-06-260000-00-00NoNoCurrent
52904-650-205290406502020 POUCH in 1 CARTON (52904-650-20) > 2 TABLET, EXTENDED RELEASE in 1 POUCH20 pouch2012-06-260000-00-00NoNoCurrent