FDA.reportPublic FDA data

NDC 42507-604-01 - 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
42507-604
Requested NDC
42507-604-01
Package NDCs from labels
42507-604-24, 42507-604-62, 42507-604-50, 42507-604-71, 42507-604-01, 42507-604-78, 42507-604-90, 42507-604-00, 42507-604-85, 42507-604-76, 42507-604-51
Manufacturer
HyVee Inc
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ibuprofen - HyVee IncHyVee Inc2026-07-16HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, FILM COATED [HYVEE INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [HYVEE INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [HYVEE INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [HYVEE INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [HYVEE INC]2

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 8 of 193 · 3,843 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVS Pharmacy52193849-d03a-b61b-e063-6394a90ad2772026-07-20WarningsExact identifier
unii: WK2XYI10QM
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
good sense dual actionACETAMINOPHEN, IBUPROFENL Perrigo Companyb117358c-f4ca-4ea8-95ee-88a42cc050402026-07-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application number: ANDA072096
ndc (package): 42507-604-85
ndc (package): 42507-604-76
ndc (package): 42507-604-78
ndc (package): 42507-604-62
ndc (package): 42507-604-24
ndc (package): 42507-604-00
ndc (package): 42507-604-01
ndc (package): 42507-604-51
ndc (package): 42507-604-71
ndc (package): 42507-604-50
ndc (package): 42507-604-90
ndc (product): 42507-604
ndc11 (package): 42507060401
rxcui: 310965
spl id: a019b2ec-e95b-4bda-ba7c-140f7ee9e7c1
spl set id: e7175dc9-db39-4452-a419-85af179de422
unii: WK2XYI10QM
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
unii: WK2XYI10QM
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENStrides Pharma Science Limited38ebacc3-378f-483e-babc-76119677e7df2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC0387bfaa-daca-48ec-b718-0216a848c16a2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
unii: WK2XYI10QM
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application number: ANDA072096
rxcui: 310965
unii: WK2XYI10QM
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
rxcui: 310965
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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