NDC 50580-433

Infants TYLENOL

Acetaminophen

Infants TYLENOL is a Oral Suspension 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 ID50580-433_6b56c7e3-63d6-41bc-a13e-7120e33069b3
NDC50580-433
Product TypeHuman Otc Drug
Proprietary NameInfants TYLENOL
Generic NameAcetaminophen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-08-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN
Active Ingredient Strength160 mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50580-433-01

1 BOTTLE in 1 CARTON (50580-433-01) > 30 mL in 1 BOTTLE
Marketing Start Date2017-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-433-02 [50580043302]

Infants TYLENOL SUSPENSION
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-29

NDC 50580-433-01 [50580043301]

Infants TYLENOL SUSPENSION
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-07

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:2143cc16-86db-4060-96da-5c228ae9207b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828555
  • 307668

    • NDC Crossover Matching brand name "Infants TYLENOL" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    50580-325Infants TYLENOLInfants TYLENOL
    50580-599Infants TYLENOLInfants TYLENOL
    50580-223Infants TYLENOLInfants TYLENOL
    50580-191Infants TYLENOLInfants TYLENOL
    50580-433Infants TYLENOLInfants TYLENOL
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.