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 18 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve Headache PainNAPROXEN SODIUMBayer HealthCare LLCc69f4926-c5cd-63a0-e053-2a95a90a2ca62025-12-04WarningsExact identifier
unii: 9TN87S3A3C
Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUMBayer HealthCare LLC.82891458-ab0d-459a-8602-dcebd22c30102025-12-04WarningsExact identifier
unii: 9TN87S3A3C
AleveNAPROXEN SODIUMBayer HealthCare LLC.00ef5b30-71d0-4cb4-84a3-48c67d1cea2a2025-12-04Exact identifier
unii: 9TN87S3A3C
Aleve Back and Muscle PainNAPROXEN SODIUMBayer HealthCare LLC.6376e1b8-52c4-0519-e053-2a91aa0af35f2025-12-04Exact identifier
unii: 9TN87S3A3C
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.a3745850-3e32-4884-b315-161bcb9996ed2025-12-04Exact identifier
unii: 9TN87S3A3C
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.acea54a2-5a92-428e-a778-bb4f9d6767822025-12-04Exact identifier
unii: 9TN87S3A3C
Aleve-D Sinus and HeadacheNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEBayer HealthCare LLC.5ab980c0-c48a-233b-e053-2991aa0a4fd12025-12-04WarningsExact identifier
unii: 9TN87S3A3C
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.0ad8bbb9-dd5f-4273-b085-ee3e5ed226132025-12-04WarningsExact identifier
unii: 9TN87S3A3C
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3c0ddd25-5a9a-4628-a971-65fe2a9775b52025-12-04WarningsExact identifier
unii: 9TN87S3A3C
AleveNAPROXEN SODIUMBayer HealthCare LLC.1266393e-b55e-4e34-9710-0b87209f41582025-12-04WarningsExact identifier
unii: 9TN87S3A3C
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3b5442c6-c6e1-4df3-8cec-40bbb4ec469f2025-12-04WarningsExact identifier
unii: 9TN87S3A3C
Aleve-D Sinus and ColdNAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDEBayer HealthCare LLC.599ea6c8-03ad-536e-e053-2991aa0a83a32025-12-04WarningsExact identifier
unii: 9TN87S3A3C
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
CAREALL NaproxenNAPROXEN SODIUMNew World Imports, Inc.d9a0c6e7-a70e-479a-9737-e81a2887c7782025-12-01WarningsExact identifier
unii: 9TN87S3A3C
CAREALL Naproxen SodiumNAPROXEN SODIUMNew World Imports, Inc.3952324e-77f4-4117-a97a-ab56511300582025-12-01WarningsExact identifier
unii: 9TN87S3A3C
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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