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 7 of 187 · 3,724 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
unii: 362O9ITL9D
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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