extra strength tylenol cold plus flu multi-action day

Generic: acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name extra strength tylenol cold plus flu multi-action day
Generic Name acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, dextromethorphan hydrobromide 15 mg/1, pseudoephedrine hydrochloride 30 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-344
Product ID 50580-344_21702ebc-459b-7f5a-e063-6294a90ad432
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-06-21

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580344
Hyphenated Format 50580-344

Supplemental Identifiers

RxCUI
1250743
UPC
0300450147240
UNII
362O9ITL9D 9D2RTI9KYH 6V9V2RYJ8N

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 extra strength tylenol cold plus flu multi-action day (source: ndc)
Generic Name acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 15 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-344-01 2 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (500 mg/1) dextromethorphan hydrobromide (15 mg/1) pseudoephedrine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Extra Strength TYLENOL Cold Plus Flu Multi-Action Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21702ebc-459b-7f5a-e063-6294a90ad432", "openfda": {"upc": ["0300450147240"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["1250743"], "spl_set_id": ["7d3266dc-879a-4d28-b8ea-74d238c3020a"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-344-01)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-344-01", "marketing_start_date": "20210621"}], "brand_name": "Extra Strength TYLENOL Cold Plus Flu Multi-Action Day", "product_id": "50580-344_21702ebc-459b-7f5a-e063-6294a90ad432", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50580-344", "generic_name": "acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Extra Strength TYLENOL Cold Plus Flu Multi-Action", "brand_name_suffix": "Day", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210621", "listing_expiration_date": "20261231"}