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 54 of 85 · 1,693 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen19d3af1c-9dd5-48d9-bd5c-05cc8745e8362025-01-04WarningsExact identifier
unii: WK2XYI10QM
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen7cd838e1-85da-4510-86f0-9d8bc913e8102025-01-03WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenb8f43352-f771-4722-b843-f3e29f77c7c02025-01-03WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack9b98fc28-6cba-4b22-8d4a-9c7735d346b42025-01-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepackb9968d61-bd5d-4573-825a-7630f86eb7c62025-01-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack5c817d24-2dd3-468e-9678-311d038c7b4a2025-01-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAsclemed USA, Inc.41123df3-97ac-4c4f-9a89-f76ec03898bb2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Exact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fc871659-ce41-1be6-e053-6294a90aa5e42025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd998f2fcf-0b40-4304-929f-7f2fa42f66d02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen, Caseys 4goodIBUPROFEN TABLETSLil' Drug Store Products, Inc.04b3ad8b-bdf9-47f3-e063-6294a90ac3502024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC09972806-e064-238d-e063-6394a90a74342024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCc859cc7a-e13a-7df4-e053-2a95a90a47d62024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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