FDA.reportPublic FDA data

Mucinex DM

Product NDC
85237-1650
11-digit product format
852371650
Labeler code
85237
Product ID
85237-1650_46fd8719-fbcb-afb5-e063-6394a90ade32
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Select Consumer Group
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 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
85237-1650-1Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22
85237-1650-2Mucinex DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
85237-1650-2Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN3c9c8fb0-8a00-4b0f-e063-6394a90af6322
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD3c9c8fb0-8a00-4b0f-e063-6394a90af6322
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY3c9c8fb0-8a00-4b0f-e063-6394a90af6322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1650-1852371650012 TABLET, EXTENDED RELEASE in 1 POUCH (85237-1650-1) 2025-12-27NoNoCurrent
85237-1650-2852371650021 POUCH in 1 BLISTER PACK (85237-1650-2) / 2 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2025-12-24NoNoCurrent