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 45 of 85 · 1,693 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENFSA STORE INC.ec6b015d-e72e-89c4-e053-2a95a90af81c2025-06-17WarningsExact identifier
unii: WK2XYI10QM
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
unii: WK2XYI10QM
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
unii: WK2XYI10QM
care one ibuprofen childrensIBUPROFENAmerican Sales Companyc56511fd-ff2e-40f6-91e6-fe04e563fafd2025-06-13WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
profen IB childrensIBUPROFENPublix Super Markets Inc1af04e26-e32c-4c1c-bbda-2c78f2030ac62025-06-13WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLCfac22a47-f0de-4505-fd8a-768430cda0c12025-06-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.47434f23-5ac9-4cb4-a963-7c8bf9e063612025-06-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.3b0e4ccc-cc0b-42fb-9163-7560740d95922025-06-11WarningsExact identifier
unii: WK2XYI10QM
Topcare Childrens IbuprofenIBUPROFENTopco Associates LLC45255d2f-c592-4750-abb5-21647d4fbd512025-06-10WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENMeijer Distribution Inc625226ef-d55b-4f93-ad1e-4fe2b07d41332025-06-10WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC37299475-e2f3-de26-e063-6394a90ad62d2025-06-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsab11e142-9e11-4ce4-9671-7e4fe53ffe922025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsf1842893-7a34-4f77-8231-55fb0c98b22b2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsExact identifier
unii: WK2XYI10QM
AMAZON BASIC CARE IBUPROFENIBUPROFENAmazon.com Services LLC113dd693-6abe-1a0f-e063-6394a90a167e2025-06-06WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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