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 20 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polygonatum CepaPOLYGONATUM CEPAUriel Pharmacy Inc.6ba0ac36-16cc-49bd-b37f-90cf18acbd5a2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Naproxen SodiumNAPROXEN SODIUMAthlete's Needs Incd5984c9d-3941-45d6-8392-87564b2faae02025-11-15WarningsExact identifier
unii: 9TN87S3A3C
Bambusa Viscum StannumBAMBUSA VISCUM STANNUMUriel Pharmacy Inc.7b2a95d0-6f51-4a6b-b05f-fe7d13d83b892025-11-14WarningsExact identifier
unii: ETJ7Z6XBU4
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
BONE HPSODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT.Natural Creations, Inc.93d2b385-9ce3-4d16-b428-1638e9a55f922025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: ETJ7Z6XBU4
Ananassa ResinaANANASSA RESINAUriel Pharmacy Inc.52a18d0a-2c97-4e81-81ff-c836582d0a4c2025-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
up and up naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTarget Corporationc0769941-bcf2-4237-b70c-a79089ad53352025-11-05WarningsExact identifier
unii: 9TN87S3A3C
dg health naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMDolgencorp Inc6c2c087c-e36d-4971-b977-d3cab6d6edee2025-11-05WarningsExact identifier
unii: 9TN87S3A3C
up and up naproxen sodiumNAPROXEN SODIUMTarget Corporation00bd8490-f280-4336-b13d-0e11c0bf45862025-11-04WarningsExact identifier
unii: 9TN87S3A3C
Rugby All Day ReliefNAPROXEN SODIUMRugby Laboratories16e107f0-45a3-428f-b849-0f20a848a6022025-10-30WarningsExact identifier
unii: 9TN87S3A3C
Leader All Day Pain ReliefNAPROXEN SODIUMCardinal Health 110, LLC. dba Leaderb01c2b4e-a092-42dc-a387-d181d8ba14bb2025-10-30WarningsExact identifier
unii: 9TN87S3A3C
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMSun Pharmaceutical Industries, Inc.96ed12a3-fa76-4afd-bee8-1ab19eb607f32025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
CALMADOL PAIN RELIEVERNAPROXEN SODIUMGRANDALL DISTRIBUTING, LLC8edec8d1-a323-436b-8329-c327438516e32025-10-28WarningsExact identifier
unii: 9TN87S3A3C
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and TeethCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC267fb775-a03c-f100-e063-6394a90aa8262025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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