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 3 of 188 · 3,746 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDRENS ACETAMINOPHENAkron Pharma Inc.cc769c26-556a-4831-bd75-61a7383aa7072026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDRENS ACETAMINOPHENAkron Pharma Inc.ebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472026-08-31WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
unii: 362O9ITL9D
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: 362O9ITL9D
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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