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 1 of 87 · 1,723 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfef89d3f-16e1-4a76-aabd-11d6eca4be862026-09-01WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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