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 10 of 18 · 349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up arthritis pain relieverDICLOFENAC SODIUMTarget Corporation0b7ae58c-cdaf-4343-a199-7a90bf901eb52025-04-27WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCc7431496-c0ef-403a-9716-92d942709b3d2025-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAmneal Pharmaceuticals LLCafd30051-8f59-474b-9972-962a5a871dfb2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMGERI-CARE PHARMACEUTICAL CORPfc08e58c-6323-e667-e053-6394a90ab7542025-04-21WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRedPharm Drug, Inc.4ecb7bdc-4a5e-7444-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DiclonaLIDOCAINE 4.5%, DICLOFENAC 1%Clinic Pharma3271f9ee-6f8a-1c68-e063-6394a90a8e3b2025-04-08Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMINNOVUS PHARMACEUTICALS, INC.ad9d2c28-21bc-4f81-9c90-cce6a96d976a2025-03-25WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPreferred Pharmaceuticals Inc.6d5243ae-4a1a-4583-9337-085520e1f14a2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.c933eaad-ba53-4130-90db-a66f89dfc29f2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCipla USA Inc.daf52f5a-1bb7-4808-ab98-483ab9e8cfa02025-03-11WarningsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Limited048ede6a-b7cd-4100-8979-519bd44906c82025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.31b56330-6870-48b7-a8c4-0639e0766b252025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Limited11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Voltaren Arthritis PainDICLOFENAC SODIUMHaleon US Holdings LLC30a94282-0892-442a-aa10-6525cbd4fe882025-02-11WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepackaf480e78-ff65-4709-af26-c430aefb77d62025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.5508f80d-5f11-4959-8e42-9055f0169cfc2025-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.0d1d19e5-4ffe-af95-e063-6394a90a7abf2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPd70fcd8e-a72b-41ef-ac26-e0f2f279f0622025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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