FDA.reportPublic FDA data

NDC 80425-0050-01 - Naproxen

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
80425-0050
Requested NDC
80425-0050-01
Package NDCs from labels
80425-0050-2, 80425-0050-1, 80425-0050-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0050-1Naproxen60 in 1 BOTTLETABLET606
80425-0050-2Naproxen90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0050NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_af9aa7a0-e287-5935-e053-2995a90a1d11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0050-1EA - Each80425-005042db3f9d-30eb-4317-9ff5-cacb1fe8161e12023-06-06
80425-0050-2EA - Each80425-0050d33960a5-6523-4a80-b4e6-0fa5094a6aad12023-06-06

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 22 · 433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
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
24/7 Life by 7-Eleven Naproxen SodiumNAPROXEN SODIUM TABLET, FILM COATEDLil' Drug Store Products, Inc.44716954-006a-4c56-e063-6294a90a0f142025-11-25WarningsExact identifier
unii: 9TN87S3A3C
Sumatriptan and Naproxen SodiumSUMATRIPTAN AND NAPROXEN SODIUMNorthStar RxLLC3f2ec27e-0e96-4028-a1fa-114e6d5014642025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
up and up naproxen sodiumNAPROXEN SODIUMTarget Corporationb0e98603-94e9-474a-88a0-22042f4612712025-11-19WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack0e7697ad-25c6-4405-9f9b-791633cb1ef72025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849431
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMP & L Development, LLC3bd60171-c073-441a-8d59-c85efee69e072025-11-17WarningsExact identifier
unii: 9TN87S3A3C
AleveNAPROXEN SODIUMR J General Corporation46e7b298-9e19-49b6-be71-e4fdcb09a5d42025-11-17WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMAthlete's Needs Incd5984c9d-3941-45d6-8392-87564b2faae02025-11-15WarningsExact identifier
unii: 9TN87S3A3C
NaproxenNAPROXENPHOENIX RX LLC43912294-77c9-eda8-e063-6394a90adf0a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
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
NaproxenNAPROXENA-S Medication Solutions8c3398bd-66b1-4a14-8aaa-e4a2d6749a082025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
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
NaproxenNAPROXENMedcore LLC129392c8-8ce1-4b78-8863-042db880095f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
CALMADOL PAIN RELIEVERNAPROXEN SODIUMGRANDALL DISTRIBUTING, LLC8edec8d1-a323-436b-8329-c327438516e32025-10-28WarningsExact identifier
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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