FDA.reportPublic FDA data

NDC 68094-600-59 - Dye Free 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
68094-600
Requested NDC
68094-600-59
Package NDCs from labels
68094-600-59, 68094-600-62, 68094-600-61
Manufacturer
Precision Dose Inc.
Effective date
2025-02-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dye Free Children's Ibuprofen Oral SuspensionPrecision Dose Inc.2025-02-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-600-59Dye Free Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION57
68094-600-61Dye Free Childrens Ibuprofen10 in 1 CASESUSPENSION107
68094-600-61Dye Free Childrens Ibuprofen10 in 1 TRAYSUSPENSION107
68094-600-62Dye Free Childrens Ibuprofen10 in 1 TRAYSUSPENSION107
68094-600-62Dye Free Childrens Ibuprofen3 in 1 CASESUSPENSION37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-600DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]7Current NDC, Legacy NDC, 5 package rows20250215_eccee4c6-aa94-468a-aebd-265d7a9efb6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-600-59ML - Milliliter68094-600daf59e83-6ab2-4178-a3f8-67ef277a72cc12015-10-02
68094-600-61ML - Milliliter68094-600942905d0-6b62-4355-bf74-0095fa4c979c12017-09-11
68094-600-62ML - Milliliter68094-600ccfaa06c-014a-4d60-a6cd-5eecaa1bb6cb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
IbuprofenACTIVE MOIETYWK2XYI10QMDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
Anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WODYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEDYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]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 · 1,755 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.