leader tussin cf (70000-0623)

Drug Facts

Product Profile

Brand Name leader tussin cf

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler cardinal health 110, llc. dba leader

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0623

Product ID 70000-0623_b82ad95f-84c2-401a-8eab-91cc1dc22a70

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Marketing Start 2023-01-31

Marketing End 2026-11-30

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 700000623

Hyphenated Format 70000-0623

Supplemental Identifiers

RxCUI

1116572

UNII

362O9ITL9D 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 tussin cf (source: ndc)

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

650 mg/20mL
20 mg/20mL
400 mg/20mL
10 mg/20mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (70000-0623-1) / 118 mL in 1 BOTTLE

source: ndc

Packages (1)

70000-0623-1 1 BOTTLE in 1 CARTON (70000-0623-1) / 118 mL in 1 BOTTLE

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

leader tussin cf ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "b82ad95f-84c2-401a-8eab-91cc1dc22a70", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["b3e3699b-b36c-453c-8f3b-0001388c8e82"], "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 (70000-0623-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0623-1", "marketing_end_date": "20261130", "marketing_start_date": "20230131"}], "brand_name": "leader tussin cf", "product_id": "70000-0623_b82ad95f-84c2-401a-8eab-91cc1dc22a70", "dosage_form": "SOLUTION", "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": "70000-0623", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader tussin cf", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261130", "marketing_start_date": "20230131"}