extra strength tylenol severe cough plus sore throat day/night

Generic: acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate

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/night
Generic Name acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate
Labeler kenvue brands llc
Dosage Form KIT
Routes
ORAL
Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-551
Product ID 50580-551_3a190315-8b55-0724-e063-6294a90a7bb5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-08-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580551
Hyphenated Format 50580-551

Supplemental Identifiers

RxCUI
247324 1098496 2604579

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/night (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg
  • 15 mg
  • 2 mg
source: label
Packaging
  • 1 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-551-01 1 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a190315-8b55-0724-e063-6294a90a7bb5", "openfda": {"rxcui": ["247324", "1098496", "2604579"], "spl_set_id": ["19ad2cca-c1cb-019c-e063-6294a90a5644"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (50580-551-01)  *  2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK *  2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-551-01", "marketing_start_date": "20240826"}], "brand_name": "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT", "product_id": "50580-551_3a190315-8b55-0724-e063-6294a90a7bb5", "dosage_form": "KIT", "product_ndc": "50580-551", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240826", "listing_expiration_date": "20261231"}