multi-symptom nighttime cold and flu relief

Generic: acetaminophen, doxylamine succinate, dextromethorphan hbr

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name multi-symptom nighttime cold and flu relief
Generic Name acetaminophen, doxylamine succinate, dextromethorphan hbr
Labeler advanced rx llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-316
Product ID 80513-316_2b205b12-58f9-161f-e063-6394a90a5a66
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

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 80513316
Hyphenated Format 80513-316

Supplemental Identifiers

RxCUI
1094549
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 multi-symptom nighttime cold and flu relief (source: ndc)
Generic Name acetaminophen, doxylamine succinate, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-316-50)
source: ndc

Packages (1)

80513-316-50 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-316-50)

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

Multi-Symptom Nighttime Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b205b12-58f9-161f-e063-6394a90a5a66", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-316-50)", "package_ndc": "80513-316-50", "marketing_start_date": "20250101"}], "brand_name": "Multi-Symptom Nighttime Cold and Flu Relief", "product_id": "80513-316_2b205b12-58f9-161f-e063-6394a90a5a66", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "80513-316", "generic_name": "Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Multi-Symptom Nighttime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}