leader cough dm (70000-0187)

Drug Facts

Product Profile

Brand Name leader cough dm

Generic Name dextromethorphan polistirex

Labeler cardinal health 110, llc. dba leader

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0187

Product ID 70000-0187_a05d5a66-fab7-47e8-b265-d2e19e9ffb13

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA091135

Listing Expiration 2026-12-31

Marketing Start 2016-12-05

Pharmacologic Class

Classes

sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000187

Hyphenated Format 70000-0187

Supplemental Identifiers

RxCUI

1373045

UNII

9D2RTI9KYH

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 cough dm (source: ndc)

Generic Name dextromethorphan polistirex (source: ndc)

Application Number ANDA091135 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (70000-0187-1) / 89 mL in 1 BOTTLE

source: ndc

Packages (1)

70000-0187-1 1 BOTTLE in 1 CARTON (70000-0187-1) / 89 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/5mL)

Linked Drug Pages (1)

Leader Cough DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a05d5a66-fab7-47e8-b265-d2e19e9ffb13", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["4c99b5e3-cd79-4c54-ae37-3673c836e668"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0187-1)  / 89 mL in 1 BOTTLE", "package_ndc": "70000-0187-1", "marketing_start_date": "20161205"}], "brand_name": "Leader Cough DM", "product_id": "70000-0187_a05d5a66-fab7-47e8-b265-d2e19e9ffb13", "dosage_form": "SUSPENSION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "70000-0187", "generic_name": "dextromethorphan polistirex", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Cough DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA091135", "marketing_category": "ANDA", "marketing_start_date": "20161205", "listing_expiration_date": "20261231"}