NDC 50580-783

Tylenol 8 HR Arthritis Pain

Acetaminophen

Tylenol 8 HR Arthritis Pain is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen.

Product ID50580-783_038eebcb-a31b-4f25-8d9d-1b9bf7e89eeb
NDC50580-783
Product TypeHuman Otc Drug
Proprietary NameTylenol 8 HR Arthritis Pain
Generic NameAcetaminophen
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-07-13
Marketing CategoryNDA / NDA
Application NumberNDA019872
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN
Active Ingredient Strength650 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-783-10

1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Start Date2015-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-783-24 [50580078324]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-13

NDC 50580-783-30 [50580078330]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-12

NDC 50580-783-29 [50580078329]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-13

NDC 50580-783-32 [50580078332]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-26

NDC 50580-783-10 [50580078310]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

NDC 50580-783-25 [50580078325]

Tylenol 8 HR Arthritis Pain TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019872
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:3af22fc8-e4e0-4863-8696-6bc1257047cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148399
  • 1243440

    • NDC Crossover Matching brand name "Tylenol 8 HR Arthritis Pain" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    50580-783Tylenol 8 HR Arthritis PainTylenol 8 HR Arthritis Pain
    0121-0657AcetaminophenAcetaminophen
    0113-7000Basic Care acetaminophenAcetaminophen
    0113-7484basic care acetaminophenAcetaminophen
    0113-7544Basic Care AcetaminophenAcetaminophen
    0113-7130basic care childrens pain and feverAcetaminophen
    0113-0020good sense childrens pain and feverAcetaminophen
    0113-0212Good Sense Childrens Pain and FeverAcetaminophen
    0113-0608good sense childrens pain and feverAcetaminophen
    0113-0998Good Sense Childrens Pain and FeverAcetaminophen
    0113-0161Good Sense pain and feverAcetaminophen
    0113-0397Good Sense Pain and Feveracetaminophen
    0113-0590Good Sense Pain and Feveracetaminophen
    0113-0946good sense pain and feverAcetaminophen
    0113-8959Good Sense Pain and FeverAcetaminophen
    0113-0025Good Sense Pain ReliefAcetaminophen
    0113-0044Good Sense Pain ReliefAcetaminophen
    0113-0187good sense pain reliefAcetaminophen
    0113-0217good sense pain reliefAcetaminophen
    0113-0227Good Sense Pain ReliefAcetaminophen
    0113-0403good sense pain reliefAcetaminophen
    0113-0484Good Sense Pain ReliefAcetaminophen
    0113-0518good sense pain reliefAcetaminophen
    0113-0544good sense pain reliefAcetaminophen
    0113-1889good sense pain reliefacetaminophen
    0113-1975Good Sense Pain ReliefAcetaminophen
    0031-9301Robitussin Direct Sore Throat Painacetaminophen
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.