NDC 50580-296-04 - Childrens TYLENOL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50580-296
Requested NDC
50580-296-04
Package NDCs from labels
50580-296-50, 50580-296-51, 50580-296-04
Manufacturer
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Effective date
2018-12-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's TYLENOL ®Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division2018-12-07HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-296-04ML - Milliliter50580-296b148ae57-3c17-4d44-9965-50a66635917d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
acetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
D&C red NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
FD&C blue NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 187 · 3,724 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
unii: 362O9ITL9D
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
unii: 362O9ITL9D
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
unii: 362O9ITL9D
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
unii: 362O9ITL9D
CareOne 8 Hour Pain ReliefACETAMINOPHENAmerican Sales Company9b2b0ef0-7071-4536-8f74-8f1d6250e1052026-08-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.