tylenol 8 hr arthritis pain

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name tylenol 8 hr arthritis pain
Generic Name acetaminophen
Labeler kenvue brands llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-783
Product ID 50580-783_26c62e88-08c4-1113-e063-6394a90ac1f8
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019872
Listing Expiration 2026-12-31
Marketing Start 2015-07-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580783
Hyphenated Format 50580-783

Supplemental Identifiers

RxCUI
1148399 1243440
UPC
0300450838216
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 8 hr arthritis pain (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number NDA019872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-25) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30)
  • 1 BOTTLE in 1 CARTON (50580-783-31) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-783-32) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 50 POUCH in 1 CARTON (50580-783-51) / 2 TABLET, EXTENDED RELEASE in 1 POUCH
source: ndc

Packages (7)

50580-783-10 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 50580-783-24 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 50580-783-25 1 BOTTLE, PLASTIC in 1 CARTON (50580-783-25) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 50580-783-30 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30) 50580-783-31 1 BOTTLE in 1 CARTON (50580-783-31) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE 50580-783-32 1 BOTTLE in 1 CARTON (50580-783-32) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 50580-783-51 50 POUCH in 1 CARTON (50580-783-51) / 2 TABLET, EXTENDED RELEASE in 1 POUCH

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Tylenol 8 HR Arthritis Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26c62e88-08c4-1113-e063-6394a90ac1f8", "openfda": {"upc": ["0300450838216"], "unii": ["362O9ITL9D"], "rxcui": ["1148399", "1243440"], "spl_set_id": ["3af22fc8-e4e0-4863-8696-6bc1257047cb"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "50580-783-10", "marketing_start_date": "20150713"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24)  / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "50580-783-24", "marketing_start_date": "20150713"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-783-25)  / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "50580-783-25", "marketing_start_date": "20150713"}, {"sample": false, "description": "290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50580-783-30)", "package_ndc": "50580-783-30", "marketing_start_date": "20180212"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-783-31)  / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-783-31", "marketing_start_date": "20220601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-783-32)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-783-32", "marketing_start_date": "20190826"}, {"sample": false, "description": "50 POUCH in 1 CARTON (50580-783-51)  / 2 TABLET, EXTENDED RELEASE in 1 POUCH", "package_ndc": "50580-783-51", "marketing_start_date": "20241122"}], "brand_name": "Tylenol 8 HR Arthritis Pain", "product_id": "50580-783_26c62e88-08c4-1113-e063-6394a90ac1f8", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "50580-783", "generic_name": "Acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol 8 HR Arthritis Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "NDA019872", "marketing_category": "NDA", "marketing_start_date": "20150713", "listing_expiration_date": "20261231"}