NDC 50580-438

Childrens TYLENOL

Acetaminophen

Childrens 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 ID50580-438_956ac5fd-01fe-4fec-ba66-f103f72cdf6e
NDC50580-438
Product TypeHuman Otc Drug
Proprietary NameChildrens TYLENOL
Generic NameAcetaminophen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-07-30
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 Through2020-12-31

Packaging

NDC 50580-438-01

2 CARTON in 1 PACKAGE (50580-438-01) > 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE
Marketing Start Date2018-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-438-01 [50580043801]

Childrens TYLENOL SUSPENSION
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:755004d5-1b30-48ff-b751-415074cf724d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828555
  • 307668
  • UPC Code
  • 0300450166043
  • NDC Crossover Matching brand name "Childrens TYLENOL" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    50580-170Childrens TYLENOLChildrens TYLENOL
    50580-424Childrens TYLENOLChildrens TYLENOL
    50580-460Childrens TylenolChildrens Tylenol
    50580-614Childrens TYLENOLChildrens TYLENOL
    50580-438Childrens TYLENOLChildrens TYLENOL
    50580-579Childrens TYLENOLChildrens TYLENOL
    50580-612Childrens TYLENOLChildrens TYLENOL
    50580-521Childrens TYLENOLChildrens TYLENOL
    50580-123Childrens TYLENOLChildrens TYLENOL
    50580-296Childrens TYLENOLChildrens TYLENOL
    50580-509Childrens TYLENOLChildrens TYLENOL
    50580-522Childrens TylenolChildrens Tylenol
    50580-555Childrens TYLENOLChildrens 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

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