FDA.reportPublic FDA data

NDC 49884-778 - 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
49884-778
Manufacturer
Contract Pharmacy Services-PA
Effective date
2009-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen - Contract Pharmacy Services-PAContract Pharmacy Services-PA2009-10-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1

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 141 of 186 · 3,710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLCfaebc392-0fd9-4c71-8471-beba10dda0222024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKROGER COMPANY15e649c4-d75f-e8c1-e063-6294a90a77472024-07-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENActavis Pharma, Inc.3d156d13-25d8-4cfc-8285-5f7ebf48cf452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals,Inc.678e2d16-33f3-67a7-e053-2991aa0a11322024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075682
rxcui: 197807
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC75d963b9-3675-44ff-bc6b-83461bed1b672024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC57cdd1df-a303-4265-a2d6-1d0b87105a282024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC8df77ead-27eb-4f6f-95a9-f68d3e9cfa712024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197806
unii: WK2XYI10QM
AdvilIBUPROFEN TABLETS, COATEDLil' Drug Store Products, Inc.dd302e18-39e9-7e1a-e053-2a95a90a5f7c2024-07-17WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.54b25106-5580-119d-e054-00144ff88e882024-07-17Exact identifier
rxcui: 197806
unii: WK2XYI10QM
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC1d625438-34dc-fbba-e063-6294a90afd2f2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen OralIBUPROFEN ORALNuCare Pharmaceuticals,Inc.84764eda-7446-5b16-e053-2991aa0abd7c2024-07-15WarningsExact identifier
unii: WK2XYI10QM
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
unii: 15FIX9V2JP
ibuprofenIBUPROFENBryant Ranch Prepack22cb2ccc-ba4d-4069-8334-f886f0e3e8022024-07-12WarningsExact identifier
unii: WK2XYI10QM
Foster and Thrive Infants IbuprofenIBUPROFENStrategic Sourcing Services LLCfe3092af-9a7b-4189-af89-31be8d6fed532024-07-12WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINECamber Pharmaceuticals, Inc.7dc158a2-fdfa-4a5f-8c28-0ce5650991db2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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