Mucus DM

Product NDC
46122-420
11-digit product format
461220420
Labeler code
46122
Product ID
46122-420_ac2755dc-dd3b-4bce-a467-3063a10e1ead
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-08-07
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus DM
Listing expiration
2026-12-31

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
46122-420-03Mucus DM7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE77
46122-420-03Mucus DM4 in 1 CARTONTABLET, EXTENDED RELEASE47
46122-420-74Mucus DM7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE77
46122-420-74Mucus DM2 in 1 CARTONTABLET, EXTENDED RELEASE27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-420-03EA - Each46122-4203372157f-c84b-4d24-b35f-072a50f8933e12019-02-13
46122-420-74EA - Each46122-420fafa22d9-ff50-47dd-b39e-cca370ac6b5a12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-420MUCUS DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN]7Current NDC, Legacy NDC, 4 package rows20240404_bf4bcec8-7136-4ae7-a459-a30ee881b98d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNbf4bcec8-7136-4ae7-a459-a30ee881b98d7
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDbf4bcec8-7136-4ae7-a459-a30ee881b98d7
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYbf4bcec8-7136-4ae7-a459-a30ee881b98d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-420-03461220420034 BLISTER PACK in 1 CARTON (46122-420-03) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2018-07-090000-00-00NoNoCurrent
46122-420-74461220420742 BLISTER PACK in 1 CARTON (46122-420-74) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-08-070000-00-00NoNoCurrent