tylenol 8 hr muscle aches and pain

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name tylenol 8 hr muscle aches and pain
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 50580-576
Product ID 50580-576_21acd9d2-84aa-3a95-e063-6394a90af438
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2024-01-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580576
Hyphenated Format 50580-576

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 8 hr muscle aches and pain (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA211544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-576-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-576-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

50580-576-01 1 BOTTLE in 1 CARTON (50580-576-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 50580-576-02 1 BOTTLE in 1 CARTON (50580-576-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

TYLENOL 8 HR MUSCLE ACHES AND PAIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21acd9d2-84aa-3a95-e063-6394a90af438", "openfda": {"upc": ["0300450297211"], "unii": ["362O9ITL9D"], "rxcui": ["1148399", "1243440"], "spl_set_id": ["037ec598-cba6-dbb6-e063-6394a90ac42c"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-576-01)  / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-576-01", "marketing_start_date": "20240130"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-576-02)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "50580-576-02", "marketing_start_date": "20240130"}], "brand_name": "TYLENOL 8 HR MUSCLE ACHES AND PAIN", "product_id": "50580-576_21acd9d2-84aa-3a95-e063-6394a90af438", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "50580-576", "generic_name": "acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL 8 HR MUSCLE ACHES AND PAIN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20240130", "listing_expiration_date": "20261231"}