mucinex dm maximum strength

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

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-072
Product ID 63824-072_324b0a12-8964-731d-e063-6394a90a00a7
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 63824072
Hyphenated Format 63824-072

Supplemental Identifiers

RxCUI
1099074
UPC
0363824072142
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 maximum strength (source: ndc)
Generic Name guaifenesin and dextromethorphan hydrobromide (source: ndc)
Application Number NDA021620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 1200 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (63824-072-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH
  • 1 BLISTER PACK in 1 CARTON (63824-072-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-072-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63824-072-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (63824-072-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-072-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-072-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (7)

63824-072-02 1 POUCH in 1 CARTON (63824-072-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH 63824-072-07 1 BLISTER PACK in 1 CARTON (63824-072-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-072-35 1 BLISTER PACK in 1 CARTON (63824-072-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-072-36 2 BLISTER PACK in 1 CARTON (63824-072-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-072-46 3 BLISTER PACK in 1 CARTON (63824-072-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-072-48 4 BLISTER PACK in 1 CARTON (63824-072-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-072-56 4 BLISTER PACK in 1 CARTON (63824-072-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Mucinex DM Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "324b0a12-8964-731d-e063-6394a90a00a7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824072142"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["588eddc1-fa30-41cc-8ed9-c01319ea21c6"], "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": "1 POUCH in 1 CARTON (63824-072-02)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH", "package_ndc": "63824-072-02", "marketing_start_date": "20210801"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-072-07)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-07", "marketing_start_date": "20120626"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-072-35)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-35", "marketing_start_date": "20120626"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-072-36)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-36", "marketing_start_date": "20120626"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63824-072-46)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-46", "marketing_start_date": "20120626"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-072-48)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-48", "marketing_start_date": "20120626"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-072-56)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-072-56", "marketing_start_date": "20210701"}], "brand_name": "Mucinex DM Maximum Strength", "product_id": "63824-072_324b0a12-8964-731d-e063-6394a90a00a7", "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": "63824-072", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex DM", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "NDA021620", "marketing_category": "NDA", "marketing_start_date": "20120626", "listing_expiration_date": "20261231"}