tylenol 8hr

Generic: acetaminophen

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

Drug Facts

Product Profile

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

acetaminophen 650 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-309
Product ID 50580-309_21e84490-8cad-bf34-e063-6394a90af940
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019872
Listing Expiration 2026-12-31
Marketing Start 2016-01-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580309
Hyphenated Format 50580-309

Supplemental Identifiers

RxCUI
1148399 1243440
UPC
0300450297211
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 8hr (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 in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

50580-309-01 1 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 50580-309-02 1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Tylenol 8HR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21e84490-8cad-bf34-e063-6394a90af940", "openfda": {"upc": ["0300450297211"], "unii": ["362O9ITL9D"], "rxcui": ["1148399", "1243440"], "spl_set_id": ["5d7d1300-bcb8-466a-880b-310b360ee132"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-309-01)  / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-309-01", "marketing_start_date": "20160118"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-309-02)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-309-02", "marketing_start_date": "20160118"}], "brand_name": "Tylenol 8HR", "product_id": "50580-309_21e84490-8cad-bf34-e063-6394a90af940", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "50580-309", "generic_name": "acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol 8HR", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "NDA019872", "marketing_category": "NDA", "marketing_start_date": "20160118", "listing_expiration_date": "20261231"}