FDA.reportPublic FDA data

NDC 68084-658-11 - 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
68084-658
Requested NDC
68084-658-11
Package NDCs from labels
68084-658-11, 68084-658-01
Manufacturer
American Health Packaging
Effective date
2020-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen - American Health PackagingAmerican Health Packaging2020-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-658-01EA - Each68084-658d4a18418-0e6c-44f5-9de3-7e6d6d1eb3c212013-11-04
68084-658-11EA - Each68084-6584781fe17-4fcc-4c95-b367-c2f0ad1d0e5512013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]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 5 of 190 · 3,782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATION4b8ad98e-de76-4f49-3b89-01e9dd5cde162026-08-06WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC159b68b7-54e5-4f83-b632-f49e7b4b14a52026-08-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Companyc118b290-f821-4e73-906e-8a93edaf34e42026-08-05WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Company8944a0e8-2928-4494-915f-d1e0a6d4bf5c2026-08-04WarningsExact identifier
unii: WK2XYI10QM
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: WK2XYI10QM
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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