FDA.reportPublic FDA data

NDC 68071-3483-01 - 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
68071-3483
Requested NDC
68071-3483-01
Package NDCs from labels
68071-3483-1, 68071-3483-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain relieverNuCare Pharmaceuticals,Inc.2024-07-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3483-1DICLOFENAC SODIUM1 in 1 CARTONGEL13
68071-3483-1DICLOFENAC SODIUM100 g in 1 TUBEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3483DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20240710_0326ea5b-3e1a-dee2-e063-6294a90a13b8.zip

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 29 of 68 · 1,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85416361-90b5-3efa-e053-2a91aa0af4312025-11-03WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8528a4f5-5ff4-45f3-e053-2991aa0a804c2025-11-03WarningsExact identifier
unii: ND2M416302
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMLupin Pharmaceuticals, Inc.609c5344-9c97-4fa8-ad53-d0f622ce64ec2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
unii: T5L8T28FGP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
unii: ND2M416302
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
unii: T5L8T28FGP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.c88b2512-0255-658d-252a-c006275159b02025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Strategic Sourcing Services, LLC5de514ee-fd59-ef95-8dc3-16e34321572b2025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Chain Drug Marketing Association INC625d21e8-0731-1157-30fe-9f9868ff8dc42025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Walgreens Company40d0553b-a97a-1315-3fca-8ef38611505e2025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Discount Drug Mart, Inc.ae1ebe9c-b1fa-6762-949e-cb83b33319a22025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Kroger Company2081371d-436a-16fc-db80-ced6288f52bc2025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%GERI-CARE PHARMACEUTICALS CORP91fc618a-edd0-5944-083f-c00075476f552025-10-28WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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