FDA.reportPublic FDA data

NDC 68788-9111-01 - 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
68788-9111
Requested NDC
68788-9111-01
Package NDCs from labels
68788-9111-2, 68788-9111-7, 68788-9111-3, 68788-9111-5, 68788-9111-6, 68788-9111-9, 68788-9111-1, 68788-9111-8, 68788-9111-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBU ™ TabletsPreferred Pharmaceuticals, Inc.2026-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9111-1Ibuprofen100 in 1 BOTTLETABLET10017
68788-9111-2Ibuprofen20 in 1 BOTTLETABLET2017
68788-9111-3Ibuprofen30 in 1 BOTTLETABLET3017
68788-9111-5Ibuprofen50 in 1 BOTTLETABLET5017
68788-9111-6Ibuprofen60 in 1 BOTTLETABLET6017
68788-9111-7Ibuprofen21 in 1 BOTTLETABLET2117
68788-9111-8Ibuprofen120 in 1 BOTTLETABLET12017
68788-9111-9Ibuprofen90 in 1 BOTTLETABLET9017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9111IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 8 package rows20240526_72ec2491-924d-460f-9510-62d624d54b59.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
IbuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
carnauba waxINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
polydextroseINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]5

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 190 · 3,782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: WK2XYI10QM
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197806
unii: WK2XYI10QM
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
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
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075682
rxcui: 197805
rxcui: 197807
rxcui: 197806
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

Reported adverse events (FAERS/openFDA)#

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