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 9 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact identifier
unii: ND2M416302
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
unii: ND2M416302
Wish Alcohol PadISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.51f87ed7-04ae-136a-e063-6294a90a95002026-05-16WarningsExact identifier
unii: ND2M416302
Alcohol prep padISOPROPYL ALCOHOL CLOTHHubei V-Medical Products co.,Ltd.51d5780e-9039-1b66-e063-6394a90a0b8a2026-05-15WarningsExact identifier
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
unii: ND2M416302
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: T5L8T28FGP
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c34af0-2b12-c5e0-e063-6394a90a41742026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
unii: ND2M416302
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6865a5cf-3263-44b5-96d9-7a7a4c6e1c052026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
caring mill Lavender Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.fcbb6b34-6f0e-4b82-8b3f-1d702d88079a2026-05-11WarningsExact identifier
unii: ND2M416302
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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