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 12 of 18 · 349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCec06cca5-3436-10c8-e053-2995a90a4aeb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208301
ndc (package): 80425-0236-1
ndc (product): 80425-0236
ndc11 (package): 80425023601
rxcui: 855642
spl id: 2a9ad9e4-1650-c0dc-e063-6294a90a6e45
spl set id: f1892aae-7267-3b4c-e053-2995a90a8802
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1896c84-b18a-d49d-e053-2995a90aaab32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7264-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf3d27ae6-1259-5375-e053-2995a90a572d2024-12-31WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf187ae44-71be-a682-e053-2995a90a64262024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAdvanced Rx Pharmacy of Tennessee, LLCfc0e6a51-bec3-f7ee-e053-6394a90ada9a2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCfc0e1950-d76f-75bc-e053-6294a90a8c122024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCaf8a1392-67e8-8201-e053-2a95a90a0fce2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMQuality Care Products, LLC3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products, LLC12e1f808-9f24-4f6d-b5bc-12ce0059ab7a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCf18a4691-93a1-01e6-e053-2995a90a00692024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, LLC.26e44aa5-cfcd-f10b-e063-6394a90a4dcf2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsExact identifier
unii: QTG126297Q
SalonpasDICLOFENAC SODIUMHisamitsu America, Inc.f439445d-046e-4220-a4a7-13d750ee09492024-11-14WarningsExact identifier
unii: QTG126297Q
MOTRIN ARTHRITIS PAINDICLOFENAC SODIUMKenvue Brands LLCdb5b4288-13ec-826b-e053-2995a90a275e2024-11-08WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackbf372e32-0902-447f-9673-00a3fcf0064c2024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPba4677e4-00f8-44f6-a69b-e88ca28f6b2b2024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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