nighttime cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Labeler: gobrands, inc. (goodnow)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler gobrands, inc. (goodnow)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Gobrands, Inc. (Goodnow)

Identifiers & Regulatory

Product NDC 82501-3431
Product ID 82501-3431_2c8d3bb5-d4df-4b54-89e2-fcc22d43adf9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-04-29

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 825013431
Hyphenated Format 82501-3431

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 nighttime cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, 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 (82501-3431-2)
source: ndc

Packages (1)

82501-3431-2 355 mL in 1 BOTTLE, PLASTIC (82501-3431-2)

Ingredients (3)

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

Linked Drug Pages (1)

Nighttime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c8d3bb5-d4df-4b54-89e2-fcc22d43adf9", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["0a04d832-9858-4423-aab9-91372725c214"], "manufacturer_name": ["Gobrands, Inc. (Goodnow)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (82501-3431-2)", "package_ndc": "82501-3431-2", "marketing_start_date": "20220429"}], "brand_name": "Nighttime Cold and Flu", "product_id": "82501-3431_2c8d3bb5-d4df-4b54-89e2-fcc22d43adf9", "dosage_form": "LIQUID", "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": "82501-3431", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate", "labeler_name": "Gobrands, Inc. (Goodnow)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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": "20220429", "listing_expiration_date": "20261231"}