FDA.reportPublic FDA data

NDC 68094-494-59 - Childrens Ibuprofen

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
68094-494
Requested NDC
68094-494-59
Package NDCs from labels
68094-494-59, 68094-494-62, 68094-494-61, 68094-494-58
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Ibuprofen - Cardinal Health 107, LLCCardinal Health 107, LLC2026-04-16HUMAN OTC DRUG LABEL
CHILDREN'S IBUPROFEN ORAL SUSPENSIONPrecision Dose Inc.2025-08-08HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-494-58Childrens Ibuprofen10 in 1 BAGSUSPENSION108
68094-494-58Childrens Ibuprofen5 in 1 CASESUSPENSION58
68094-494-59Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION58
68094-494-61Childrens Ibuprofen10 in 1 CASESUSPENSION108
68094-494-61Childrens Ibuprofen10 in 1 TRAYSUSPENSION108
68094-494-62Childrens Ibuprofen3 in 1 CASESUSPENSION38
68094-494-62Childrens Ibuprofen10 in 1 TRAYSUSPENSION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-494CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]7Current NDC, Legacy NDC, 7 package rows20250302_fbbc67a7-359f-4155-9367-3815c05ccf03.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-494-58ML - Milliliter68094-4944aba43c3-9f5d-4ff0-94d3-03f8c73142a412012-07-24
68094-494-59ML - Milliliter68094-494ebbd55aa-94b0-485f-9ad2-f8b71d98cd9612012-07-24
68094-494-61ML - Milliliter68094-4940d5aabe9-f0f1-4bad-b9a4-054ca6ec7dad12012-07-24
68094-494-62ML - Milliliter68094-494b89b32c2-d731-4fea-bf52-26447774c88a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
corn syrupINACTIVE INGREDIENT9G5L16BK6NCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
D&C red NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]2

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 2 of 87 · 1,723 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGobrands, Inc. (Goodnow)04e1b176-b74a-413e-a8e1-dd3764b9aa8b2026-09-01WarningsExact identifier
unii: WK2XYI10QM
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: WK2XYI10QM
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.57f06daf-690d-44a7-95a5-4687329497502026-08-19WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENNuCare Pharmaceuticals,Inc.59554a62-3a9a-c0f3-e063-6294a90ad3fd2026-08-18WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC0865fe8a-df81-4ae4-8bed-29a022ba164f2026-08-17WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
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

Reported adverse events (FAERS/openFDA)#

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