NDC 50580-378

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 ID50580-378_06687c5d-fe46-400d-a84a-c6d755baa252
NDC50580-378
Product TypeHuman Otc Drug
Proprietary NameTylenol Extra Strength
Generic NameAcetaminophen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-11-01
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 Through2021-12-31

Packaging

NDC 50580-378-01

1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-378-01 [50580037801]

Tylenol Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-11-01

NDC 50580-378-03 [50580037803]

Tylenol Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-06

NDC 50580-378-02 [50580037802]

Tylenol Extra Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-11-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:17cfa99d-abb2-4d77-9e0e-e77109fbb61a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 209459
  • 198440
  • 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

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