FDA.reportPublic FDA data

NDC 85534-0013-01 - 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
85534-0013
Requested NDC
85534-0013-01
Package NDCs from labels
85534-0013-0, 85534-0013-1, 85534-0013-2, 85534-0013-3, 85534-0013-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen Tablets, USP Rx onlyHAWAII REPACK, INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL

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 57 of 192 · 3,827 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVSe45830a0-c884-e556-e053-2995a90ab5652025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVSf0d3f0ab-07ee-f068-e053-2995a90a481a2025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreens07edb8d0-2fa8-4b40-e063-6294a90a2fe92025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENFamily Dollarfe095058-5ecb-75b3-e053-6394a90afb6c2025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFamily Dollarfe17f5a6-fd6d-d839-e053-6394a90a59a42025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RITE AIDe64c0ec1-2889-96d1-e053-2995a90a85682025-12-19WarningsExact identifier
unii: WK2XYI10QM
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Sand Cloud Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff477199-9b01-fc90-e053-6294a90a51022025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Sand Cloud Mineral Sunscreen For FaceTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff2346c6-d911-87b3-e053-6394a90ac6f82025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - ShellTITANIUM DIOXIDE, ZINC OXIDERodan & Fields12c63195-8707-4df0-a4d3-6f31c543db7a2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENA-S Medication Solutionsf24582be-8d70-4848-bd54-e55fa28f394f2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213794
rxcui: 197807
unii: WK2XYI10QM
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
unii: 15FIX9V2JP
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
unii: 15FIX9V2JP
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3c1a61b-88fc-419c-e053-2a95a90ac0c32025-12-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.8c3ca03e-0ec2-c15c-e053-2995a90ad8bd2025-12-18WarningsExact identifier
unii: WK2XYI10QM
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
unii: 15FIX9V2JP
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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