tylenol regular strength

Generic: acetaminophen

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

Drug Facts

Product Profile

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

acetaminophen 325 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-475
Product ID 50580-475_398d8996-b523-a3cd-e063-6394a90ac2c8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-08-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580475
Hyphenated Format 50580-475

Supplemental Identifiers

RxCUI
209387 313782
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 regular strength (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-475-10) / 1000 TABLET, FILM COATED in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (50580-475-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (50580-475-50) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

50580-475-10 1 BOTTLE in 1 CARTON (50580-475-10) / 1000 TABLET, FILM COATED in 1 BOTTLE 50580-475-11 10 BLISTER PACK in 1 CARTON (50580-475-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 50580-475-50 1 BOTTLE in 1 CARTON (50580-475-50) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

acetaminophen (325 mg/1)

Linked Drug Pages (1)

TYLENOL Regular Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "398d8996-b523-a3cd-e063-6394a90ac2c8", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["209387", "313782"], "spl_set_id": ["398d8996-b522-a3cd-e063-6394a90ac2c8"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-475-10)  / 1000 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-475-10", "marketing_start_date": "20250830"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (50580-475-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-475-11", "marketing_start_date": "20250830"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-475-50)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-475-50", "marketing_start_date": "20250830"}], "brand_name": "TYLENOL Regular Strength", "product_id": "50580-475_398d8996-b523-a3cd-e063-6394a90ac2c8", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50580-475", "generic_name": "Acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL", "brand_name_suffix": "Regular Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250830", "listing_expiration_date": "20261231"}