leader childrens multi symptom cold

Generic: dextromethorphan hbr, guaifenesin, 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 leader childrens multi symptom cold
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0629
Product ID 70000-0629_8e10d570-5e78-4ff3-9a30-bbdba6912b74
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

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 700000629
Hyphenated Format 70000-0629

Supplemental Identifiers

RxCUI
1043543
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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 childrens multi symptom cold (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0629-1) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0629-1 1 BOTTLE in 1 CARTON (70000-0629-1) / 118 mL in 1 BOTTLE

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Leader Childrens Multi Symptom Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8e10d570-5e78-4ff3-9a30-bbdba6912b74", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1043543"], "spl_set_id": ["169ff9cf-fcf5-46a6-b460-259421f2ec07"], "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 (70000-0629-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0629-1", "marketing_start_date": "20230315"}], "brand_name": "Leader Childrens Multi Symptom Cold", "product_id": "70000-0629_8e10d570-5e78-4ff3-9a30-bbdba6912b74", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70000-0629", "generic_name": "Dextromethorphan HBr, guaifenesin, Phenylephrine HCl", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Childrens Multi Symptom Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}