FDA.reportPublic FDA data

MUCUS RELIEF - DM

Product NDC
73581-405
11-digit product format
735810405
Labeler code
73581
Product ID
73581-405_3ce33efd-e300-a7e2-e063-6394a90ad2c1
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
YYBA CORP
Application
ANDA214781
Marketing category
ANDA
Marketing start
2025-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MUCUS RELIEF - DM
Brand name suffix
MAXIMUM STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73581-405-982025-08-21C16284748780-13b156c62-3492-fb37-e063-e6dba90a4e07WELMATE Mucus Relief DM 98ct 73581-404
73581-405-982025-07-29C16284748780-13b156c62-3492-fb37-e063-e6dba90a4e07WELMATE Mucus Relief DM 98ct 73581-404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-405-98MUCUS RELIEF - DMMAXIMUM STRENGTH98 in 1 BLISTER PACKTABLET, EXTENDED RELEASE982

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-405MUCUS RELIEF - DM MAXIMUM STRENGTH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [YYBA CORP]1Current NDC, 1 package rows20250410_325b5e55-ba58-312c-e063-6394a90aee55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN325b5e55-ba58-312c-e063-6394a90aee552
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD325b5e55-ba58-312c-e063-6394a90aee552
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY325b5e55-ba58-312c-e063-6394a90aee552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73581-405-987358104059898 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (73581-405-98) 2025-04-01NoNoCurrent