leader childrens cold and cough

Generic: brompheniramine maleate, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name leader childrens cold and cough
Generic Name brompheniramine maleate, dextromethorphan hydrobromide
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0715
Product ID 70000-0715_d6f60235-73ff-4ebe-9940-c21f8dd2b3c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-01-06

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 700000715
Hyphenated Format 70000-0715

Supplemental Identifiers

RxCUI
2683421
UNII
IXA7C9ZN03 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 childrens cold and cough (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 10 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0715-1) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0715-1 1 BOTTLE in 1 CARTON (70000-0715-1) / 118 mL in 1 BOTTLE

Ingredients (2)

brompheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL)

Linked Drug Pages (1)

Leader Childrens Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6f60235-73ff-4ebe-9940-c21f8dd2b3c5", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH"], "rxcui": ["2683421"], "spl_set_id": ["207b2677-aaad-4fe4-a96d-963b7dcfba70"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0715-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0715-1", "marketing_start_date": "20250106"}], "brand_name": "Leader Childrens Cold and Cough", "product_id": "70000-0715_d6f60235-73ff-4ebe-9940-c21f8dd2b3c5", "dosage_form": "SOLUTION", "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": "70000-0715", "generic_name": "brompheniramine maleate, dextromethorphan hydrobromide", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Childrens Cold and Cough", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250106", "listing_expiration_date": "20261231"}