FDA.reportPublic FDA data

Mucus Relief DM Cough

Product NDC
50844-633
11-digit product format
508440633
Labeler code
50844
Product ID
50844-633_149a0797-addc-4029-b646-5ce00b50664e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM Cough
Listing expiration
2027-12-31

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
50844-633-11Mucus Relief DM Cough60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
50844-633-11Mucus Relief DM Cough1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-633MUCUS RELIEF DM COUGH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4Current NDC, 2 package rows20250418_2fea3533-8218-4875-affe-5b33a22c553a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN2fea3533-8218-4875-affe-5b33a22c553a5
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD2fea3533-8218-4875-affe-5b33a22c553a5
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY2fea3533-8218-4875-affe-5b33a22c553a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50844-633-11508440633111 BOTTLE, PLASTIC in 1 CARTON (50844-633-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-08-07NoNoCurrent