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 50580-457
Product ID 50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2020-07-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580457
Hyphenated Format 50580-457

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 (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 10 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70)
source: ndc

Packages (3)

50580-457-10 1 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50580-457-11 10 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 50580-457-70 700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70)

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": "2ddb1260-fde6-1914-e063-6394a90a82d7", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440", "209459"], "spl_set_id": ["c830320e-72ba-48ff-a4cd-250ac5650bf0"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-457-10)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50580-457-10", "marketing_start_date": "20200710"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (50580-457-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-457-11", "marketing_start_date": "20200717"}, {"sample": false, "description": "700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70)", "package_ndc": "50580-457-70", "marketing_start_date": "20200717"}], "brand_name": "TYLENOL Extra Strength", "product_id": "50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50580-457", "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": "20200710", "listing_expiration_date": "20261231"}