leader daytime cold and flu

Generic: acetaminophen, dextromethorphan hbr, 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 cold and flu
Generic Name acetaminophen, dextromethorphan hbr, 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, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0191
Product ID 70000-0191_216b2b43-c73d-4caf-91ce-75eb63e78301
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2016-12-14

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 700000191
Hyphenated Format 70000-0191

Supplemental Identifiers

RxCUI
1113705
UNII
362O9ITL9D 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 leader daytime cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (70000-0191-1)
  • 355 mL in 1 BOTTLE (70000-0191-2)
source: ndc

Packages (2)

70000-0191-1 237 mL in 1 BOTTLE (70000-0191-1) 70000-0191-2 355 mL in 1 BOTTLE (70000-0191-2)

Ingredients (3)

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

Linked Drug Pages (1)

Leader Daytime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "216b2b43-c73d-4caf-91ce-75eb63e78301", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["333c7042-95b8-4d98-9df1-4287017afa36"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (70000-0191-1)", "package_ndc": "70000-0191-1", "marketing_start_date": "20161214"}, {"sample": false, "description": "355 mL in 1 BOTTLE (70000-0191-2)", "package_ndc": "70000-0191-2", "marketing_start_date": "20170111"}], "brand_name": "Leader Daytime Cold and Flu", "product_id": "70000-0191_216b2b43-c73d-4caf-91ce-75eb63e78301", "dosage_form": "SOLUTION", "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": "70000-0191", "generic_name": "acetaminophen, dextromethorphan Hbr, Phenylephrine HCl", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Daytime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161214", "listing_expiration_date": "20261231"}