FDA.reportPublic FDA data

NDC 50844-417-43 - 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
50844-417
Requested NDC
50844-417-43
Package NDCs from labels
50844-417-43, 50844-417-22, 50844-417-11, 50844-417-99, 50844-417-98, 50844-417-19, 50844-417-56, 50844-417-14, 50844-417-16
Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2026-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quality Plus 44-417 and 44-604L.N.K. International, Inc. | LNK International, Inc.2026-02-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-417-11Naproxen Sodium60 in 1 CARTONTABLET, FILM COATED6015
50844-417-14Naproxen Sodium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015
50844-417-16Naproxen Sodium1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100015
50844-417-19Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED115
50844-417-19Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-417-22Naproxen Sodium48 in 1 CARTONTABLET, FILM COATED4815
50844-417-43Naproxen Sodium1 in 1 POUCHTABLET, FILM COATED115
50844-417-56Naproxen Sodium25 in 1 BOTTLE, PLASTICTABLET, FILM COATED2515
50844-417-98Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-417-99Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-417NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]13Current NDC, Legacy NDC, 10 package rows20250116_717518e4-2537-4229-b765-c6acfe963d4b.zip

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 19 of 149 · 2,963 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
AnaDentNAPROXEN SODIUMBelmora LLC236674db-da4d-415c-a160-7086eaf5bff52026-03-03WarningsExact identifier
application number: ANDA204872
rxcui: 849574
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyefe4352f-856b-4ada-8bd4-0a78423447dc2026-02-27WarningsExact identifier
rxcui: 849574
unii: 9TN87S3A3C
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
ResilienceCEREBRUM SUIS, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, SEROTONIN (HYDROCHLORIDE), NPY (NEUROPEPTIDE Y), CALCAREA CARBONICA, SILICEA, VERATRUM ALBUM, BLATTA AMERICANA, CACAO, DIOSPYROS KAKI, FORMICA RUFA, PALOONDO, SULPHUR, TAXUS BACCATA, TELA ARANEAE, SALIX VITELLINA, FLOSDeseret Biologicals, Inc.3aa6c1e7-2bd9-4c2d-bfd4-63ffb7c62e9c2026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum HarmonyBLATTA AMERICANA, CEREBRUM SUIS, CACAO, COLUMBUS PALUMBA, HEART (SUIS), DIOSPYROS KAKI, FORMICA RUFA, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, PALOONDO, NPY (NEUROPEPTIDE Y), SEROTONIN (HYDROCHLORIDE), SILICEA, SULPHUR, VERATRUM ALBUM, SALIX VITELLINA, FLOSDeseret Biologicals, Inc.1742ac50-ec6e-4261-a0b8-791b893742ef2026-02-25WarningsExact identifier
unii: ETJ7Z6XBU4
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
Naproxen SodiumNAPROXEN SODIUML.N.K. International, Inc.717518e4-2537-4229-b765-c6acfe963d4b2026-02-25WarningsExact identifier
application number: ANDA204872
ndc (package): 50844-604-14
ndc (package): 50844-417-22
ndc (package): 50844-604-98
ndc (package): 50844-604-06
ndc (package): 50844-604-19
ndc (package): 50844-417-56
ndc (package): 50844-604-99
ndc (package): 50844-417-99
ndc (package): 50844-417-43
ndc (package): 50844-417-14
ndc (package): 50844-417-19
ndc (package): 50844-604-09
ndc (package): 50844-417-16
ndc (package): 50844-604-56
ndc (package): 50844-417-98
ndc (package): 50844-417-11
ndc (package): 50844-604-15
ndc (package): 50844-604-16
ndc (product): 50844-604
ndc (product): 50844-417
ndc11 (package): 50844041743
rxcui: 849574
spl id: 89d3ed35-e75c-41d8-aa99-57cc1fd866d2
spl set id: 717518e4-2537-4229-b765-c6acfe963d4b
unii: 9TN87S3A3C
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Naproxen sodiumNAPROXEN SODIUMPHOENIX RX LLC47d18804-d8d6-8248-e063-6394a90a48a92026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Outdoor AllergiesACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLENNaturalCareb0a76faa-a081-4cee-ae40-e5605458bec32026-02-23WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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