FDA.reportPublic FDA data

NDC 42507-166-00 - ibuprofen childrens

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
42507-166
Requested NDC
42507-166-00
Package NDCs from labels
42507-166-26, 42507-166-28, 42507-166-00, 42507-166-18
Manufacturer
HyVee Inc
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ibuprofen childrens - HyVee IncHyVee Inc2026-04-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-166-00ibuprofenchildrens118 mL in 1 BOTTLESUSPENSION1187
42507-166-18ibuprofenchildrens1 in 1 CARTONSUSPENSION17
42507-166-26ibuprofenchildrens120 mL in 1 BOTTLESUSPENSION1207
42507-166-26ibuprofenchildrens1 in 1 CARTONSUSPENSION17
42507-166-28ibuprofenchildrens148 mL in 1 BOTTLESUSPENSION1487
42507-166-28ibuprofenchildrens1 in 1 CARTONSUSPENSION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [HYVEE 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 52 of 85 · 1,693 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENAurobindo Pharma Limited00872852-680a-41b3-901b-b991b12a176d2025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Dye Free Childrens IbuprofenIBUPROFENPrecision Dose Inc.eccee4c6-aa94-468a-aebd-265d7a9efb6d2025-02-12WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBrisk Pharmaceuticals2dcbe4bb-fb24-e827-e063-6394a90acf9f2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen infants DropsIBUPROFENHarris Teeter, LLC2c39a24f-4e42-d75f-e063-6394a90a60fa2025-02-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fae53f7b-3948-2566-e053-6394a90aae362025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENHarris Teeter, LLC2bb186c8-f791-5f1f-e063-6294a90a87ff2025-02-04WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.0bee69ff-cf76-175e-e063-6294a90a42f62025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AN12 Secret Therapy Feminine CleanserGLYCERINBESTVALUE Co., Ltdd2117c4c-9f1a-3a6e-e053-2995a90a0cc82025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 Skin Therapy Vita-B Aloe Soothing GelGLYCERINBESTVALUE Co., Ltdd274c973-057d-1c9f-e053-2995a90a82b12025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 ANUS PREMIUM CLEANSERGLYCERIN, ALLANTOINBESTVALUE Co., Ltdd11b7443-2dfc-3e17-e053-2a95a90afb762025-01-31WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC2cf7412a-7f94-e39f-e063-6294a90a5bc22025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd2457c045-0b7c-48f4-9422-11623f13d8f12025-01-29WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltdefb728f2-fe74-4833-8f0c-710d833abf6e2025-01-27WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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