FDA.reportPublic FDA data

NDC 68094-503-59 - 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
68094-503
Requested NDC
68094-503-59
Package NDCs from labels
68094-503-59, 68094-503-62, 68094-503-61
Manufacturer
Precision Dose Inc.
Effective date
2025-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHILDREN'S IBUPROFEN ORAL SUSPENSIONPrecision Dose Inc.2025-08-08HUMAN OTC DRUG LABEL
Childrens Ibuprofen - Cardinal HealthCardinal Health2018-10-26HUMAN 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
68094-503-59Childrens Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION105
68094-503-61Childrens Ibuprofen10 in 1 CASESUSPENSION105
68094-503-61Childrens Ibuprofen10 in 1 TRAYSUSPENSION105
68094-503-62Childrens Ibuprofen3 in 1 CASESUSPENSION35
68094-503-62Childrens Ibuprofen10 in 1 TRAYSUSPENSION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-503CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 5 package rows20250110_59b881f9-1830-4bce-99d2-9770c9b2575f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-503-59ML - Milliliter68094-5037686d365-f568-49b3-a6e7-76b30dfdd0c312012-07-24
68094-503-61ML - Milliliter68094-503a421cc2c-3207-4256-9196-b4c59a63211412012-07-24
68094-503-62ML - Milliliter68094-50333e14671-0323-4a30-88c2-308e9e9295be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
D&C yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
FD&C red NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]1

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 88 · 1,756 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
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
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

Reported adverse events (FAERS/openFDA)#

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