FDA.reportPublic FDA data

NDC 59115-002-99 - Naproxen Sodium

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
59115-002
Requested NDC
59115-002-99
Package NDCs from labels
59115-002-99
Manufacturer
Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC
Effective date
2012-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen Sodium - Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLCHikma Pharmaceutical | Al Hikma Pharmaceuticals LLC2012-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3

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 48 · 956 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company8e150c00-8e5b-40b4-a964-cb70442c27522026-05-11WarningsExact identifier
unii: 9TN87S3A3C
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsExact identifier
unii: 9TN87S3A3C
all day reliefNAPROXEN SODIUMPublix Super Markets Inc0f8843be-50a3-442c-9016-d9da3b444f602026-05-06WarningsExact identifier
unii: 9TN87S3A3C
rugby all day reliefNAPROXEN SODIUMRugby Laboratoriesf587a428-291c-4c54-80fe-244a961b05212026-05-06WarningsExact identifier
unii: 9TN87S3A3C
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Naproxen SodiumNAPROXEN SODIUMAmazon.com Services LLC04a298dc-c525-8198-e063-6294a90a6f962026-04-27WarningsExact identifier
unii: 9TN87S3A3C
ALL NIGHT PAIN RELIEF PMDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMWalgreen Company43e4ed28-b1be-4548-86ac-f40f9f83f04e2026-04-27WarningsExact identifier
unii: 9TN87S3A3C
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
unii: 9TN87S3A3C
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
AleveNAPROXEN SODIUMNavajo Manufacturing Company Inc.590f3be2-20df-4643-9114-e7ed4cf9155c2026-04-08WarningsExact identifier
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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