FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
68016-674
11-digit product format
680160674
Labeler code
68016
Product ID
68016-674_1730a5b2-b308-4dfb-813c-0536d0b91ea3
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA209692
Marketing category
ANDA
Marketing start
2019-11-29
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Brand name suffix
Maximum Strength

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-674-14Mucus Relief DMMaximum Strength1 in 1 BLISTER PACKTABLET14
68016-674-14Mucus Relief DMMaximum Strength14 in 1 CARTONTABLET144
68016-674-28Mucus Relief DMMaximum Strength1 in 1 BLISTER PACKTABLET14
68016-674-28Mucus Relief DMMaximum Strength28 in 1 CARTONTABLET284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-674MUCUS RELIEF DM MAXIMUM STRENGTH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG CONSORTIUM, LLC]3Current NDC, Legacy NDC, 4 package rows20231021_d6aae1a1-0ab9-4b26-9f62-b8761014bb35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNd6aae1a1-0ab9-4b26-9f62-b8761014bb354
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDd6aae1a1-0ab9-4b26-9f62-b8761014bb354
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd6aae1a1-0ab9-4b26-9f62-b8761014bb354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-674-146801606741414 BLISTER PACK in 1 CARTON (68016-674-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2019-11-292026-12-31NoNoCurrent
68016-674-286801606742828 BLISTER PACK in 1 CARTON (68016-674-28) / 1 TABLET in 1 BLISTER PACK28 blister pack2019-11-292026-12-31NoNoCurrent