nighttime cold and flu relief softgels multi-symptom

Generic: acetaminophen, dextromethorphan hbr, 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 softgels multi-symptom
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler advanced rx llc
Dosage Form CAPSULE, GELATIN COATED
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 80513-302
Product ID 80513-302_220d53b9-4208-092d-e063-6394a90a9b0a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-04-24

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 80513302
Hyphenated Format 80513-302

Supplemental Identifiers

RxCUI
1094549
UPC
0380513000606
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 softgels multi-symptom (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, 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, GELATIN COATED in 1 BOTTLE (80513-302-50)
source: ndc

Packages (1)

80513-302-50 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-302-50)

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 SOFTGELS MULTI-SYMPTOM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "220d53b9-4208-092d-e063-6394a90a9b0a", "openfda": {"upc": ["0380513000606"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["fa1b60b1-49cb-1211-e053-6394a90a0a46"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-302-50)", "package_ndc": "80513-302-50", "marketing_start_date": "20230424"}], "brand_name": "NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM", "product_id": "80513-302_220d53b9-4208-092d-e063-6394a90a9b0a", "dosage_form": "CAPSULE, GELATIN COATED", "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": "80513-302", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NIGHTTIME COLD AND FLU RELIEF SOFTGELS", "brand_name_suffix": "MULTI-SYMPTOM", "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": "20230424", "listing_expiration_date": "20261231"}