extra strength tylenol severe cough plus sore throat day

Generic: acetaminophen 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 severe cough plus sore throat day
Generic Name acetaminophen 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

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-446
Product ID 50580-446_3a1abd26-c0a9-8a65-e063-6294a90ab66e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-08-26

Pharmacologic Class

Classes
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 50580446
Hyphenated Format 50580-446

Supplemental Identifiers

RxCUI
247324
UPC
0300450157348
UNII
362O9ITL9D 9D2RTI9KYH

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 severe cough plus sore throat day (source: ndc)
Generic Name acetaminophen and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-446-01 2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

acetaminophen (500 mg/1) dextromethorphan hydrobromide (15 mg/1)

Linked Drug Pages (1)

EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a1abd26-c0a9-8a65-e063-6294a90ab66e", "openfda": {"upc": ["0300450157348"], "unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["247324"], "spl_set_id": ["1a17b24a-8022-4e2f-e063-6294a90af276"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-446-01)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-446-01", "marketing_start_date": "20240826"}], "brand_name": "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY", "product_id": "50580-446_3a1abd26-c0a9-8a65-e063-6294a90ab66e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "50580-446", "generic_name": "Acetaminophen and Dextromethorphan Hydrobromide", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240826", "listing_expiration_date": "20261231"}