FDA.reportPublic FDA data

NDC 42507-050-80 - ibuprofen pm

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
42507-050
Requested NDC
42507-050-80
Package NDCs from labels
42507-050-60, 42507-050-58, 42507-050-80, 42507-050-27
Manufacturer
HyVee Inc
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ibuprofen pm - HyVee IncHyVee Inc2026-01-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-050-27ibuprofen pm1 in 1 CARTONTABLET, FILM COATED15
42507-050-58ibuprofen pm1 in 1 CARTONTABLET, FILM COATED15
42507-050-58ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED405
42507-050-60ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED205
42507-050-60ibuprofen pm1 in 1 CARTONTABLET, FILM COATED15
42507-050-80ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED805

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, 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 6 of 189 · 3,779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL MIGRAINEIBUPROFENHaleon US Holdings LLCe4a6219d-4ad4-0119-4cf8-7fc39b4b59792026-07-29WarningsExact identifier
unii: WK2XYI10QM
AdvilIBUPROFENHaleon US Holdings LLC1f01c10a-9434-91a4-2ee4-352315a6b6102026-07-29WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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