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
Label	Manufacturer	Effective date	Type
Naproxen Sodium - Hikma Pharmaceutical \| Al Hikma Pharmaceuticals LLC	Hikma Pharmaceutical \| Al Hikma Pharmaceuticals LLC	2012-07-16	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NAPROXEN 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 45 of 47 · 922 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Post-Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	90bb15e5-3d9d-e2e2-e053-2995a90a85ac	2020-11-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
GUNA MATRIX DETOX	SODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -	Guna spa	a369b95b-4d57-f149-e053-2995a90a87e3	2020-10-23	Warnings, Adverse reactions	Exact identifier unii: ETJ7Z6XBU4
Supreme	ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA	BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE	72c4679b-aa97-4888-9178-581d0f99c0b6	2020-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	397db794-027c-4a89-993e-07c208b457a3	2020-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9TN87S3A3C
Flanax Pain Reliever/Fever reducer	NAPROXEN SODIUM	Belmora LLC	05337e0b-8baf-42d6-a642-3052f77ed304	2020-05-29	Warnings	Exact identifier unii: 9TN87S3A3C
Ana-Dent PAIN RELIEF	NAPROXEN SODIUM	Belmora LLC	04721306-2850-4e0a-9dd9-7cabb575f3c7	2020-05-18	Warnings	Exact identifier unii: 9TN87S3A3C
Flanax Pain Reliever/Fever Reducer	NAPROXEN SODIUM	Belmora LLC	a93e4966-9dd3-40ba-b7d6-6ca8fef229c6	2020-05-15	Warnings	Exact identifier unii: 9TN87S3A3C
NAPROXEN SODIUM	NAPROXEN SODIUM	PuraCap Pharmaceutical LLC	fc865e81-164c-48e9-8fb9-6fc27d1c33cf	2019-12-10	Warnings	Exact identifier unii: 9TN87S3A3C
NAPROXEN SODIUM	NAPROXEN SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	1d5981dd-e3f5-48a3-a5f1-ce49689cdfac	2019-11-08	Warnings	Exact identifier unii: 9TN87S3A3C
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	c0dc7f87-355c-4357-b99d-f03693d350a7	2019-11-01	Warnings	Exact identifier unii: 9TN87S3A3C
Naproxen Caplets	NAPROXEN SODIUM 220 MG	Allegiant Health	07120764-7c33-4c07-9367-40956d970c60	2019-06-06	Warnings	Exact identifier unii: 9TN87S3A3C
Naproxen Sodium	NAPROXEN SODIUM	SA3, LLC	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	2019-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9TN87S3A3C
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sinus Relief	ASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUM	Homeocare Laboratories	84483171-df92-47de-9203-ed02d64fb5fb	2018-12-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hair-X Hair Loss Relief	CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS	Homeocare Laboratories	00b62179-e03b-4972-902d-3a0c969b59bc	2018-12-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
GUNA-SINUS NOSE	ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -	Guna spa	36fef678-17c6-4d2a-a0f0-ddb298611f25	2018-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Gastrozen	COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC	Natural Creations, Inc	98dd756f-6774-47c3-bdfb-deff82fb801d	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Runny Nose CP	ALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHUR	Natural Creations, Inc	868ec0ad-9344-4f94-b2c1-2abb48479b15	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mold Antigen	ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC	Zorex International	ff92e909-b5a7-417f-98a4-551f1576fd1e	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nausea CP	AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR	Natural Creations, Inc	2746cde1-577b-41d6-9f22-93d8f1a2c235	2018-12-21	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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