NDC 50580-449

TYLENOL Extra Strength

Acetaminophen

TYLENOL Extra Strength is a Oral Tablet, Film Coated 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 ID50580-449_214d91b4-ae1b-4641-9d89-0e87f00c0752
NDC50580-449
Product TypeHuman Otc Drug
Proprietary NameTYLENOL Extra Strength
Generic NameAcetaminophen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1984-08-19
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-449-00

1 BOTTLE, PLASTIC in 1 CARTON (50580-449-00) > 125 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date1984-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-449-05 [50580044905]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-34 [50580044934]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-23 [50580044923]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-86 [50580044986]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-98 [50580044998]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-28

NDC 50580-449-84 [50580044984]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-96 [50580044996]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-25

NDC 50580-449-14 [50580044914]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-31 [50580044931]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-35 [50580044935]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-13 [50580044913]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-46 [50580044946]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19
Marketing End Date2013-07-30

NDC 50580-449-15 [50580044915]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-85 [50580044985]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-87 [50580044987]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-10 [50580044910]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-36 [50580044936]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-62 [50580044962]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-12 [50580044912]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-10-21

NDC 50580-449-00 [50580044900]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

NDC 50580-449-97 [50580044997]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-28

NDC 50580-449-07 [50580044907]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19
Marketing End Date2014-06-13

NDC 50580-449-08 [50580044908]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-11 [50580044911]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-61 [50580044961]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1984-08-19

NDC 50580-449-09 [50580044909]

TYLENOL Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1984-08-19

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:59773893-09a8-47a2-943a-e9ea9da4458a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 209459
  • 198440
    • UPC Code
  • 0300450449054

    • NDC Crossover Matching brand name "TYLENOL Extra Strength" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    67751-167Tylenol Extra StrengthTylenol Extra Strength
    50090-0005TYLENOL Extra StrengthTYLENOL Extra Strength
    50090-1695Tylenol Extra StrengthTylenol Extra Strength
    50269-449Tylenol Extra StrengthTylenol Extra Strength
    50580-412TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-692TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-451TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-590TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-449TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-488TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-378Tylenol Extra StrengthTylenol Extra Strength
    66715-9747TYLENOL EXTRA STRENGTHTYLENOL EXTRA STRENGTH
    73097-012Tylenol Extra StrengthTylenol Extra Strength
    50580-937Tylenol Extra StrengthTylenol Extra Strength
    50269-008Tylenol Extra StrengthTylenol Extra Strength
    50580-457TYLENOL Extra StrengthTYLENOL Extra Strength
    50580-209TYLENOL Extra StrengthTYLENOL Extra Strength
    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.