FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
50804-858
11-digit product format
508040858
Labeler code
50804
Product ID
50804-858_59c98354-f90d-4db6-988c-a9b3bac8b31e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-30
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-858-302023-02-11C16284748780-1f386c649-bf94-0266-e053-dadaa90a7c1aDrug Facts
50804-858-302023-01-30C16284748780-1f386c649-bf94-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-858-30Mucus Relief DM30 in 1 BOTTLE, PLASTICTABLET305
50804-858-30Mucus Relief DM1 in 1 BOXTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-858MUCUS RELIEF DM (GUAIFENESIN) TABLET [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]4Current NDC, Legacy NDC, 2 package rows20240404_8857ac96-5810-41eb-b275-a4eb04c721aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN8857ac96-5810-41eb-b275-a4eb04c721aa5
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD8857ac96-5810-41eb-b275-a4eb04c721aa5
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY8857ac96-5810-41eb-b275-a4eb04c721aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-858-30508040858301 BOTTLE, PLASTIC in 1 BOX (50804-858-30) / 30 TABLET in 1 BOTTLE, PLASTIC2020-06-302026-06-30NoNoCurrent