FDA.reportPublic FDA data

NDC 80425-0273-01 - DICLOENAC SODIUM and MISOPROSTOL DR

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
80425-0273
Requested NDC
80425-0273-01
Package NDCs from labels
80425-0273-1, 80425-0273-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DICLOENAC SODIUM and MISOPROSTOL DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0273-1DICLOENAC SODIUM and MISOPROSTOLDR60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0273DICLOENAC SODIUM AND MISOPROSTOL DR (DICLOENAC SODIUM AND MISOPROSTOL) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20240224_f4d8c198-63e1-3109-e053-2995a90acad9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0273-1EA - Each80425-02733eacc955-b88d-467e-9b61-60fb0611f42812023-04-07

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 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions58063c26-86fe-4f03-97ef-51706e5f40542025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug37362eb4-db16-f4ad-e063-6394a90a42aa2025-12-13WarningsExact identifier
unii: QTG126297Q
UP AND UP ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTarget Corporation3a9b32af-a3cd-496b-9698-0421443e03852025-12-08WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALSOLA Pharmaceuticalsc3f33952-44a8-71b2-e053-2a95a90abda22025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsExact identifier
unii: QTG126297Q
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATEASCLEMED USA INC.263f64d5-da3e-43cc-a651-2136f3b1f2ea2025-12-02WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALProficient Rx LP140a2c64-4996-4da3-b10f-1b8235ebde9d2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Inc.30c3c3c5-b4f3-4321-ae25-b2c588ad05512025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
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

Reported adverse events (FAERS/openFDA)#

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