leader nighttime cold and flu

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name leader nighttime cold and flu
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL, doxylamine succinate 12.5 mg/30mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0183
Product ID 70000-0183_86f5a760-e9a2-4a8a-a171-6f75dfece706
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-11-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000183
Hyphenated Format 70000-0183

Supplemental Identifiers

RxCUI
1043400
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

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 nighttime cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 30 mg/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (70000-0183-2)
source: ndc

Packages (1)

70000-0183-2 237 mL in 1 BOTTLE (70000-0183-2)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL) doxylamine succinate (12.5 mg/30mL)

Linked Drug Pages (1)

Leader Nighttime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86f5a760-e9a2-4a8a-a171-6f75dfece706", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (70000-0183-2)", "package_ndc": "70000-0183-2", "marketing_start_date": "20161116"}], "brand_name": "Leader Nighttime Cold and Flu", "product_id": "70000-0183_86f5a760-e9a2-4a8a-a171-6f75dfece706", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "70000-0183", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Nighttime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161116", "listing_expiration_date": "20261231"}