nighttime cold and flu relief

Generic: acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate

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

Drug Facts

Product Profile

Brand Name nighttime cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
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 80513-304
Product ID 80513-304_14ddc061-b1ab-5f66-e063-6394a90af806
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 80513304
Hyphenated Format 80513-304

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 nighttime cold and flu relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate (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 (80513-304-50)
source: ndc

Packages (1)

80513-304-50 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-304-50)

Ingredients (3)

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

Linked Drug Pages (1)

NIGHTTIME COLD AND FLU RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14ddc061-b1ab-5f66-e063-6394a90af806", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["d1542362-19c5-4470-89e8-87d26e2ca8ed"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-304-50)", "package_ndc": "80513-304-50", "marketing_start_date": "20240301"}], "brand_name": "NIGHTTIME COLD AND FLU RELIEF", "product_id": "80513-304_14ddc061-b1ab-5f66-e063-6394a90af806", "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": "80513-304", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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": "20240301", "listing_expiration_date": "20261231"}