FDA.reportPublic FDA data

NDC 80425-0378-01 - 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
80425-0378
Requested NDC
80425-0378-01
Package NDCs from labels
80425-0378-1, 80425-0378-2, 80425-0378-3, 80425-0378-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-03-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-03-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0378-1Naproxen30 in 1 BOTTLETABLET301
80425-0378-2Naproxen60 in 1 BOTTLETABLET601
80425-0378-3Naproxen90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0378NAPROXEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240322_1431b769-5535-78d6-e063-6394a90a8423.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0378-1EA - Each80425-0378387b65e2-7bdd-4a8e-979e-912308ac18d912024-04-05
80425-0378-2EA - Each80425-0378cdc2c520-a361-4582-9368-034ccf67b71812024-04-05
80425-0378-3EA - Each80425-037818e03221-0151-4b55-8081-6b6081b3d7b212024-04-05

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 5 of 11 · 204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen SodiumNAPROXEN SODIUMGlenmark Pharmaceuticals Inc., USA6c5bb008-e66f-4ef0-bf84-aca7eb5983e92025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198014
rxcui: 198013
rxcui: 198012
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAjanta Pharma USA Inc.7ca657dc-4376-4693-8568-99351fac81862025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENSunrise Pharmaceutical, Inc.f2fb222a-b854-4e6f-9027-2e08aed241852025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENPHOENIX RX LLC43912294-77c9-eda8-e063-6394a90adf0a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENA-S Medication Solutions8c3398bd-66b1-4a14-8aaa-e4a2d6749a082025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
NaproxenNAPROXENMedcore LLC129392c8-8ce1-4b78-8863-042db880095f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212517
rxcui: 198014
unii: 57Y76R9ATQ
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.a9f9ce81-9d51-4167-9581-974866a8fe312025-10-17WarningsExact identifier
rxcui: 198014
unii: 57Y76R9ATQ
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.6368a3be-4b79-466b-8ec4-11fc3ac623cc2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ

Reported adverse events (FAERS/openFDA)#

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