FDA.reportPublic FDA data

NDC 42507-897-00 - 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
42507-897
Requested NDC
42507-897-00
Package NDCs from labels
42507-897-00, 42507-897-26, 42507-897-28
Manufacturer
HyVee Inc
Effective date
2026-02-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ibuprofen - HyVee IncHyVee Inc2026-02-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-897-00ibuprofen118 mL in 1 BOTTLESUSPENSION1187
42507-897-26ibuprofen1 in 1 CARTONSUSPENSION17
42507-897-28ibuprofen148 mL in 1 BOTTLESUSPENSION1487
42507-897-28ibuprofen1 in 1 CARTONSUSPENSION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [HYVEE INC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [HYVEE INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [HYVEE INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [HYVEE INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [HYVEE INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [HYVEE INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [HYVEE INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [HYVEE INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [HYVEE INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [HYVEE INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [HYVEE INC]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [HYVEE INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN 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 2 of 86 · 1,715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGobrands, Inc. (Goodnow)04e1b176-b74a-413e-a8e1-dd3764b9aa8b2026-09-01WarningsExact identifier
unii: WK2XYI10QM
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: WK2XYI10QM
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.57f06daf-690d-44a7-95a5-4687329497502026-08-19WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENNuCare Pharmaceuticals,Inc.59554a62-3a9a-c0f3-e063-6294a90ad3fd2026-08-18WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC0865fe8a-df81-4ae4-8bed-29a022ba164f2026-08-17WarningsExact identifier
application number: ANDA074937
rxcui: 197803
unii: WK2XYI10QM
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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