FDA.reportPublic FDA data

NDC 68071-2239-01 - 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
68071-2239
Requested NDC
68071-2239-01
Package NDCs from labels
68071-2239-1, 68071-2239-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-01-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2239-12022-02-07C16284748780-1d6a99b39-fa3c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988
68071-2239-12022-01-28C16284748780-1d6a99b39-fa3c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2239-1Diclofenac Sodium100 g in 1 TUBEGEL1004
68071-2239-1Diclofenac Sodium1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2239DICLOFENAC SODIUM GEL [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20250104_ad193f94-f8d0-8482-e053-2995a90a35a4.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 40 of 67 · 1,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up arthritis pain relieverDICLOFENAC SODIUMTarget Corporation0b7ae58c-cdaf-4343-a199-7a90bf901eb52025-04-27WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCc7431496-c0ef-403a-9716-92d942709b3d2025-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
unii: ND2M416302
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
unii: ND2M416302
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
unii: ND2M416302
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
unii: ND2M416302
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAmneal Pharmaceuticals LLCafd30051-8f59-474b-9972-962a5a871dfb2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMGERI-CARE PHARMACEUTICAL CORPfc08e58c-6323-e667-e053-6394a90ab7542025-04-21WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
unii: ND2M416302
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
unii: ND2M416302
Walgreens 91% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.21f204f9-a271-0062-e063-6294a90addcc2025-04-10WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMRedPharm Drug, Inc.4ecb7bdc-4a5e-7444-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
unii: ND2M416302
DiclonaLIDOCAINE 4.5%, DICLOFENAC 1%Clinic Pharma3271f9ee-6f8a-1c68-e063-6394a90a8e3b2025-04-08Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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