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 9 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMBetter Living Brands, LLC3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c0412026-02-13WarningsExact identifier
unii: 9TN87S3A3C
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC369911ea-9069-9c45-e063-6394a90a5ce62026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC36996557-3227-b753-e063-6394a90a7b6f2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMH E B4281faf5-7182-404f-9f53-3d9ea0354a182026-02-12WarningsExact identifier
unii: 9TN87S3A3C
Topcare All Day Pain ReliefNAPROXEN SODIUMTopco Associates LLC7f1cda40-9a67-4de1-af56-ab881c6354c42026-02-11WarningsExact identifier
unii: 9TN87S3A3C
naproxen sodiumNAPROXEN SODIUMH E B2f9439bb-e808-4c54-ba61-f75f117c8b372026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Back and Muscle PainNAPROXEN SODIUMRite Aid Corporatione162bd50-f94a-4c76-8f1b-62114f2838092026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMPadagis Israel Pharmaceuticals Ltdcdb60f74-ce23-4015-90eb-b23a2275f6cb2026-02-11WarningsExact identifier
unii: 9TN87S3A3C
Naproxen sodiumNAPROXEN SODIUMA-S Medication Solutions8181bb7a-d917-4388-bcb0-a74671b07b062026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack83dd8829-7ba0-4a8d-a979-41a5e077c49f2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
topcare back and muscle painNAPROXEN SODIUMTopco Associates LLCde587e8f-38f2-4e7a-8e6a-64e48f280c4f2026-02-07WarningsExact identifier
unii: 9TN87S3A3C
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Naproxen SodiumNAPROXEN SODIUMMeijer Distribution Incdb87d1da-8507-4bbf-aefc-3dbd48cde26b2026-02-05WarningsExact identifier
unii: 9TN87S3A3C
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC4a05ca8c-1b03-fa86-e063-6394a90a41192026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Rugby All Day ReliefNAPROXEN SODIUMBryant Ranch Prepack3238dfdc-82d1-4afb-b27c-0ba0a5d247442026-02-04WarningsExact identifier
unii: 9TN87S3A3C
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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