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 18 of 18 · 357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP947c0c1f-3573-4f69-ab82-8b50c43e55862022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC047985ea-f768-4f9a-bfe3-0acf40a4781d2022-02-15WarningsExact identifier
unii: QTG126297Q
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSandoz Inc52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b2021-09-29Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82021-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Proficient Rx LP7e98952e-9b95-4296-9c23-c0ff4b82b2b72021-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.f3f60cd3-8f1f-4ca4-9621-805b4a6c35a82021-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMAsclemed USA, Inc.57d8513a-820a-46c5-b0c8-5aa1811b0e882020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Asclemed USA, Inc.988abe66-0b3b-4c13-87b4-adc913227fc52020-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP20107264-e533-4de9-9a37-59fde7981c922020-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.1e39f8d4-56a2-4d29-a971-495574e8d4a72020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP7bc185e2-e749-4a24-8550-c2f6d39222d22020-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb0f9e649-6651-406f-a9fe-157fe04d9d272020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPa7447467-79e0-436e-a273-d1ddd06169cf2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP77c3cb56-c071-4d92-a0d6-022417a27de42019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAphena Pharma Solutions - Tennessee, LLCe4af374a-1281-46af-a0a9-48820db6c9472018-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNovel Laboratories, Inc.c99f5ef6-c777-4896-a5e7-7335257439b22016-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857700
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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