FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
80513-407
11-digit product format
805130407
Labeler code
80513
Product ID
80513-407_2d617549-ae71-6142-e063-6394a90accc7
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
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
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
80513-407-09MUCUS RELIEF DM90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-407MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [ADVANCED RX LLC]1Current NDC, 1 package rows20250207_64620186-a45b-4c35-a3b9-a347348f93f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN64620186-a45b-4c35-a3b9-a347348f93f71
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD64620186-a45b-4c35-a3b9-a347348f93f71
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY64620186-a45b-4c35-a3b9-a347348f93f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80513-407-098051304070990 TABLET in 1 BOTTLE (80513-407-09) 90 tablet2025-01-01NoNoHistorical