leader mucus relief dm

Generic: dextromethorphan hydrobromide, guaifenesin

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader mucus relief dm
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0722
Product ID 70000-0722_99191c05-4026-49b5-a594-e46f1b197695
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207602
Listing Expiration 2026-12-31
Marketing Start 2025-03-08

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 700000722
Hyphenated Format 70000-0722

Supplemental Identifiers

RxCUI
1298324
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 leader mucus relief dm (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number ANDA207602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0722-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

70000-0722-1 1 BOTTLE in 1 CARTON (70000-0722-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Leader Mucus Relief DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99191c05-4026-49b5-a594-e46f1b197695", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["7c54d128-9da7-49d7-bda4-9d4f7b8bc652"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0722-1)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "70000-0722-1", "marketing_start_date": "20250308"}], "brand_name": "Leader Mucus Relief DM", "product_id": "70000-0722_99191c05-4026-49b5-a594-e46f1b197695", "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": "70000-0722", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Mucus Relief DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA207602", "marketing_category": "ANDA", "marketing_start_date": "20250308", "listing_expiration_date": "20261231"}