tylenol extra strength

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name tylenol extra strength
Generic Name acetaminophen
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-378
Product ID 50580-378_48dff3c9-329f-1300-e063-6294a90a47ef
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2014-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580378
Hyphenated Format 50580-378

Supplemental Identifiers

RxCUI
198440 209459
UNII
362O9ITL9D

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 tylenol extra strength (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-02) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03)
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-04) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-06) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-07) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08)
source: ndc

Packages (8)

50580-378-01 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-02 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-02) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-03 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03) 50580-378-04 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-04) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-05 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-06 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-06) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-07 1 BOTTLE, PLASTIC in 1 CARTON (50580-378-07) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-378-08 325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

Tylenol Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48dff3c9-329f-1300-e063-6294a90a47ef", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440", "209459"], "spl_set_id": ["17cfa99d-abb2-4d77-9e0e-e77109fbb61a"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-01", "marketing_start_date": "20141101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-02)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-02", "marketing_start_date": "20141101"}, {"sample": false, "description": "225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03)", "package_ndc": "50580-378-03", "marketing_start_date": "20150406"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-04)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-04", "marketing_start_date": "20210301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-05)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-05", "marketing_start_date": "20210301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-06)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-06", "marketing_start_date": "20210301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-378-07)  / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-378-07", "marketing_start_date": "20210301"}, {"sample": false, "description": "325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08)", "package_ndc": "50580-378-08", "marketing_start_date": "20210301"}], "brand_name": "Tylenol Extra Strength", "product_id": "50580-378_48dff3c9-329f-1300-e063-6294a90a47ef", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50580-378", "generic_name": "Acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol Extra Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141101", "listing_expiration_date": "20271231"}