leader tussin dm

Generic: dextromethorphan hydrobromide, guaifenesin

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

Drug Facts

Product Profile

Brand Name leader tussin dm
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 200 mg/20mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0596
Product ID 70000-0596_19e85362-406a-45fd-8efe-5e12cbbb610c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-11-24

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 700000596
Hyphenated Format 70000-0596

Supplemental Identifiers

RxCUI
1790650
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 tussin dm (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 200 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0596-1) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0596-2) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

70000-0596-1 1 BOTTLE in 1 CARTON (70000-0596-1) / 118 mL in 1 BOTTLE 70000-0596-2 1 BOTTLE in 1 CARTON (70000-0596-2) / 237 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (200 mg/20mL)

Linked Drug Pages (1)

leader tussin dm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19e85362-406a-45fd-8efe-5e12cbbb610c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["b418c10c-528b-4395-944e-af959b639ec2"], "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 (70000-0596-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0596-1", "marketing_start_date": "20211124"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0596-2)  / 237 mL in 1 BOTTLE", "package_ndc": "70000-0596-2", "marketing_start_date": "20211124"}], "brand_name": "leader tussin dm", "product_id": "70000-0596_19e85362-406a-45fd-8efe-5e12cbbb610c", "dosage_form": "SOLUTION", "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": "70000-0596", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader tussin dm", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211124", "listing_expiration_date": "20261231"}