FDA.reportPublic FDA data

NDC 80425-0237-01 - 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
80425-0237
Requested NDC
80425-0237-01
Package NDCs from labels
80425-0237-1, 80425-0237-01
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
80425-0237-1Diclofenac Sodium150 mL in 1 BOTTLESOLUTION1504
80425-0237-1Diclofenac Sodium1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0237DICLOFENAC SODIUM SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, 2 package rows20250102_f1896c84-b18a-d49d-e053-2995a90aaab3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0237-1ML - Milliliter80425-0237e028fbd8-98bc-4f4a-97fa-fd08d74407b312023-03-13

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 9 of 18 · 357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%BluePoint Laboratories274543d2-a9a6-1e37-e063-6394a90ae3f12025-08-11WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLMicro Labs Limitedc61df58d-d6bb-4d3e-9ef8-60caa7d4e7622025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
OrthaphenDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLC1583e691-5823-4a68-aafc-bf80b88542332025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3a4f7301-aa1c-9064-e063-6294a90a6eb42025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPHOENIX RX LLC3a63e26f-27d7-9a25-e063-6294a90a55fe2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.39e67a90-df3e-ad30-e063-6394a90a7a822025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.f9a0c654-5f77-430f-b921-295eb776cbcd2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvagen Pharma Ltdac2b4060-a5da-4ddf-a734-2ff58a1f98c92025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.aa1e1ed3-0444-4bf5-a0ee-5d21a7fca3912025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMChain Drug Consortium, LLC8879a2ed-6c66-4489-8adc-9f160241cc7d2025-06-25WarningsExact identifier
unii: QTG126297Q
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Companyc30353da-acd6-474f-8a64-abd078bf4f852025-06-11WarningsExact identifier
unii: QTG126297Q
members mark arthritis pain relieverDICLOFENAC SODIUMSam's West Inc44533b5b-73ce-4853-9eda-506426cb9b822025-06-09WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLBryant Ranch Prepack7225385c-501c-4e90-8948-8617d583108c2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.363764a0-e0a8-3e3f-e063-6294a90ad6722025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC45321aec-368d-4ca4-a0c5-2ce56fae74b22025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.40879600-ba6c-43a8-aa5d-d0d41503d5932025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATESTRAND HEALTH GROUP2d92d378-2e9c-f9d5-e063-6294a90ac7152025-05-21WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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