mucinex dm

Generic: guaifenesin and dextromethorphan hydrobromide

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex dm
Generic Name guaifenesin and dextromethorphan hydrobromide
Labeler rb health (us) llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-056
Product ID 63824-056_324ae895-9603-57d1-e063-6394a90aaf45
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021620
Listing Expiration 2026-12-31
Marketing Start 2012-06-26

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63824056
Hyphenated Format 63824-056

Supplemental Identifiers

RxCUI
1298324
UPC
0363824056203
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mucinex dm (source: ndc)
Generic Name guaifenesin and dextromethorphan hydrobromide (source: ndc)
Application Number NDA021620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
  • 600 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (63824-056-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50)
  • 3 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)
  • 24 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)
  • 2 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-056-89) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (10)

63824-056-01 5 BLISTER PACK in 1 CARTON (63824-056-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-32 1 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-34 2 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-36 1 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50) 63824-056-69 3 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-72 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72) 63824-056-74 24 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73) 63824-056-80 2 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-056-89 4 BLISTER PACK in 1 CARTON (63824-056-89) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucinex DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "324ae895-9603-57d1-e063-6394a90aaf45", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824056203"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["70987d06-d206-445f-bd0d-5e1345b8465c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (63824-056-01)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-01", "marketing_start_date": "20120626"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-056-32)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-32", "marketing_start_date": "20120626"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-056-34)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-34", "marketing_start_date": "20120626"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-056-36)  / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-36", "marketing_start_date": "20120626"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50)", "package_ndc": "63824-056-50", "marketing_start_date": "20210601"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63824-056-69)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-69", "marketing_start_date": "20120626"}, {"sample": false, "description": "2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)", "package_ndc": "63824-056-72", "marketing_start_date": "20120626"}, {"sample": false, "description": "24 POUCH in 1 CARTON (63824-056-74)  / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)", "package_ndc": "63824-056-74", "marketing_start_date": "20120626"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-056-80)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-80", "marketing_start_date": "20240501"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-056-89)  / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-056-89", "marketing_start_date": "20180330"}], "brand_name": "Mucinex DM", "product_id": "63824-056_324ae895-9603-57d1-e063-6394a90aaf45", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "63824-056", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "NDA021620", "marketing_category": "NDA", "marketing_start_date": "20120626", "listing_expiration_date": "20261231"}