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 13 of 18 · 349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Company8e53e5fa-fda2-4e3a-8c5a-82435e3d51c32024-11-01WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepackae0add8e-3a8a-4c5d-af3b-907f64211fef2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions70156824-e5dd-42b1-9b4f-a49acb28d3162024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc2e3e6de9-7e07-4df3-9fea-ac50ddcde8402024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf5b4e308-c156-4865-95ee-1a8e267535ba2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions4500bf3c-394b-4397-8751-8dac2097fc412024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.22f4b8aa-902f-a860-e063-6394a90ada262024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Gencare-Arthritis Pain ReliefDICLOFENAC SODIUMPioneer Life Sciences, LLC4b1438bb-8591-4237-abcb-91491f34ad8f2024-09-10WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMHarris Teeter17ed520d-bfbe-4a33-e063-6394a90aa0f62024-08-30WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.200c2800-a703-e138-e063-6394a90acc092024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2bebda5e-227e-4a49-80e3-191cfc8052952024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions203f96bb-ae63-475c-b7a6-03c0dbc435972024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack12cce748-a7de-4b1e-9603-b5c2ce12d5312024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2b7462e6-62dc-4b08-9fbf-5858e356a7a82024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMEXELAN PHARMACEUTICALS INC.be25c19e-cbea-4f87-a581-9f0d350e5adf2024-08-02WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b82024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.4b44ac98-225c-1739-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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