childrens cold and cough

Generic: brompheniramine maleate, dextromethorphan, phenylephrine hcl

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

Drug Facts

Product Profile

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

brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0631
Product ID 70000-0631_2f0dba2c-067f-4fa3-aa6b-0a052fc7a4e3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-03-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000631
Hyphenated Format 70000-0631

Supplemental Identifiers

RxCUI
1090463
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ

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 childrens cold and cough (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 10 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0631-1) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0631-1 1 BOTTLE in 1 CARTON (70000-0631-1) / 118 mL in 1 BOTTLE

Ingredients (3)

brompheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Childrens Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f0dba2c-067f-4fa3-aa6b-0a052fc7a4e3", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["24c1f90c-7b2e-4e86-a2f6-d23f74e0708b"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0631-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0631-1", "marketing_start_date": "20230330"}], "brand_name": "Childrens Cold and Cough", "product_id": "70000-0631_2f0dba2c-067f-4fa3-aa6b-0a052fc7a4e3", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70000-0631", "generic_name": "Brompheniramine maleate, Dextromethorphan, Phenylephrine HCl", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cold and Cough", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230330", "listing_expiration_date": "20261231"}