cold and flu nighttime

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 cold and flu nighttime
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 70000-0673
Product ID 70000-0673_63a65b41-85eb-430d-bfc4-3df7bfff5b00
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-08-02

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 700000673
Hyphenated Format 70000-0673

Supplemental Identifiers

RxCUI
1043400
UPC
0096295143300
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 cold and flu nighttime (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
  • 355 mL in 1 BOTTLE, PLASTIC (70000-0673-1)
source: ndc

Packages (1)

70000-0673-1 355 mL in 1 BOTTLE, PLASTIC (70000-0673-1)

Ingredients (3)

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

Linked Drug Pages (1)

Cold and Flu Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "63a65b41-85eb-430d-bfc4-3df7bfff5b00", "openfda": {"upc": ["0096295143300"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["b1c2055b-4b5a-4fa2-b600-8930c9c8524c"], "manufacturer_name": ["Cardinal Health 110, LLC. DBA Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (70000-0673-1)", "package_ndc": "70000-0673-1", "marketing_start_date": "20240802"}], "brand_name": "Cold and Flu Nighttime", "product_id": "70000-0673_63a65b41-85eb-430d-bfc4-3df7bfff5b00", "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": "70000-0673", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate", "labeler_name": "Cardinal Health 110, LLC. DBA Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu", "brand_name_suffix": "Nighttime", "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": "20240802", "listing_expiration_date": "20261231"}