FDA.reportPublic FDA data

MUCINEX DM

Product NDC
50090-1077
11-digit product format
500901077
Labeler code
50090
Product ID
50090-1077_8c13782f-fcfa-4c99-96f6-8352f0bbfe1a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021620
Marketing category
NDA
Marketing start
2012-06-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 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
MUCINEX DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1077-0MUCINEX DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2016
50090-1077-0MUCINEX DM1 in 1 CARTONTABLET, EXTENDED RELEASE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1077-0EA - Each50090-1077c0b0a658-cf74-4e8e-95ad-007610a38ea312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1077MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20231210_fcaf1df9-b396-44f2-94ce-e46e80aba66c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNfcaf1df9-b396-44f2-94ce-e46e80aba66c16
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDfcaf1df9-b396-44f2-94ce-e46e80aba66c16
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYfcaf1df9-b396-44f2-94ce-e46e80aba66c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1077-0500901077001 BLISTER PACK in 1 CARTON (50090-1077-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent