leader daytime severe cold and flu

Generic: acetaminophen, 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 daytime severe cold and flu
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, guaifenesin 200 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0192
Product ID 70000-0192_89165902-d4db-43a8-a6d4-588417001930
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-11-23

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 700000192
Hyphenated Format 70000-0192

Supplemental Identifiers

RxCUI
1369842
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 daytime severe cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 200 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (70000-0192-1)
source: ndc

Packages (1)

70000-0192-1 237 mL in 1 BOTTLE (70000-0192-1)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) guaifenesin (200 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

Leader Daytime Severe Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "89165902-d4db-43a8-a6d4-588417001930", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["d38537c6-9553-4e93-a83e-11ed48c955ab"], "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": "237 mL in 1 BOTTLE (70000-0192-1)", "package_ndc": "70000-0192-1", "marketing_start_date": "20161123"}], "brand_name": "Leader Daytime Severe Cold and Flu", "product_id": "70000-0192_89165902-d4db-43a8-a6d4-588417001930", "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": "70000-0192", "generic_name": "acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Daytime Severe Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161123", "listing_expiration_date": "20261231"}