daytime cold and flu relief softgels non-drowsy

Generic: acetaminophen, dextromethorphan hbr, phenylephrine

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

Drug Facts

Product Profile

Brand Name daytime cold and flu relief softgels non-drowsy
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine
Labeler advanced rx llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, diphenhydramine hydrochloride 5 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-301
Product ID 80513-301_220d0f73-1573-686b-e063-6394a90a9a50
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
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] 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 80513301
Hyphenated Format 80513-301

Supplemental Identifiers

UPC
0380513000590
UNII
362O9ITL9D 9D2RTI9KYH TC2D6JAD40

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 daytime cold and flu relief softgels non-drowsy (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50)
source: ndc

Packages (1)

80513-301-50 50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50)

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) diphenhydramine hydrochloride (5 mg/1)

Linked Drug Pages (1)

DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "220d0f73-1573-686b-e063-6394a90a9a50", "openfda": {"upc": ["0380513000590"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "TC2D6JAD40"], "spl_set_id": ["fa1a4d86-87bb-0c50-e053-6394a90a56e2"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50)", "package_ndc": "80513-301-50", "marketing_start_date": "20230424"}], "brand_name": "DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY", "product_id": "80513-301_220d0f73-1573-686b-e063-6394a90a9a50", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "80513-301", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DAYTIME COLD AND FLU RELIEF SOFTGELS", "brand_name_suffix": "NON-DROWSY", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230424", "listing_expiration_date": "20261231"}