FDA.reportPublic FDA data

NDC 80425-0236-01 - Diclofenac 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
80425-0236
Requested NDC
80425-0236-01
Package NDCs from labels
80425-0236-1, 80425-0236-01
Manufacturer
Advanced Rx Pharmacy 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
Diclofenac Sodium - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0236-1Diclofenac Sodium100 g in 1 TUBEGEL1003
80425-0236-1Diclofenac Sodium1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0236DICLOFENAC SODIUM GEL [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_f1892aae-7267-3b4c-e053-2995a90a8802.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0236-1GM - Gram80425-02368b6c02cf-1b11-4a7f-bdf7-3de21d2555b412023-03-13

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 7 of 18 · 349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Inc.30c3c3c5-b4f3-4321-ae25-b2c588ad05512025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurobindo Pharma Limitede5c0863a-edb7-4f46-a396-c9b2d8785cf82025-11-19WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLCb8072af2-9940-4827-9fbd-de46ad8bf9292025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALPHOENIX RX LLC3b40a448-3f5e-fe6f-e063-6394a90a32df2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMH E B027803c5-85ae-4b86-8bd4-e61f8f34d0362025-11-17WarningsExact identifier
unii: QTG126297Q
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMMeijer, Inc.5cc570c6-2585-4d1a-9352-b1161458af9a2025-11-17WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPHOENIX RX LLC41472cca-278b-934b-e063-6294a90aaf5d2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC4382cc15-8978-4f3b-e063-6394a90a9ecb2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Topical 1%DICLOFENAC SODIUMYYBA CORP043df5d2-6f3e-311f-e063-6294a90a23d72025-11-10WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC0b4fd47f-903c-097b-e063-6394a90a49ab2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMLupin Pharmaceuticals, Inc.609c5344-9c97-4fa8-ad53-d0f622ce64ec2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.c88b2512-0255-658d-252a-c006275159b02025-10-28WarningsExact identifier
unii: QTG126297Q
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Strategic Sourcing Services, LLC5de514ee-fd59-ef95-8dc3-16e34321572b2025-10-28WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Chain Drug Marketing Association INC625d21e8-0731-1157-30fe-9f9868ff8dc42025-10-28WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Walgreens Company40d0553b-a97a-1315-3fca-8ef38611505e2025-10-28WarningsExact identifier
unii: QTG126297Q
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Discount Drug Mart, Inc.ae1ebe9c-b1fa-6762-949e-cb83b33319a22025-10-28WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Kroger Company2081371d-436a-16fc-db80-ced6288f52bc2025-10-28WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%GERI-CARE PHARMACEUTICALS CORP91fc618a-edd0-5944-083f-c00075476f552025-10-28WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMGLENMARK PHARMACEUTICALS INC., USAdab3ae60-0135-43b3-a1d0-8752720af82a2025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208301
ndc (product): 68462-355
rxcui: 855642
spl id: 6c2982e4-c4a4-4985-82d1-e418c5e055e1
spl set id: dab3ae60-0135-43b3-a1d0-8752720af82a
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC41da2e11-58c7-9622-e063-6394a90a9fdb2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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