FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
50804-432
11-digit product format
508040432
Labeler code
50804
Product ID
50804-432_54b3c3cc-9664-417d-8ffe-391708e4c58a
Type
HUMAN OTC DRUG
Nonproprietary name
Mucus Relief DM
Dosage form
TABLET
Route
ORAL
Labeler
Good Sense
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-18
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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
Immediate Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1147685

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-432-30Mucus Relief DMImmediate Release1 in 1 CARTONTABLET13
50804-432-30Mucus Relief DMImmediate Release30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-432-30EA - Each50804-4320dc7016f-3ef4-47c0-8922-2bfa0dccdd6112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-432MUCUS RELIEF DM IMMEDIATE RELEASE (MUCUS RELIEF DM) TABLET [GOOD SENSE]3Current NDC, Legacy NDC, 2 package rows20231108_26a199bf-57e5-4f36-b40c-83a1187e4870.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN26a199bf-57e5-4f36-b40c-83a1187e48703
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD26a199bf-57e5-4f36-b40c-83a1187e48703
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY26a199bf-57e5-4f36-b40c-83a1187e48703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-432-30508040432301 BOTTLE in 1 CARTON (50804-432-30) / 30 TABLET in 1 BOTTLE1 bottle2022-05-180000-00-00NoNoCurrent