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 41 of 67 · 1,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
unii: ND2M416302
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: T5L8T28FGP
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMINNOVUS PHARMACEUTICALS, INC.ad9d2c28-21bc-4f81-9c90-cce6a96d976a2025-03-25WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
unii: ND2M416302
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPreferred Pharmaceuticals Inc.6d5243ae-4a1a-4583-9337-085520e1f14a2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.c933eaad-ba53-4130-90db-a66f89dfc29f2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCipla USA Inc.daf52f5a-1bb7-4808-ab98-483ab9e8cfa02025-03-11WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Limited048ede6a-b7cd-4100-8979-519bd44906c82025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.31b56330-6870-48b7-a8c4-0639e0766b252025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Limited11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
VennGel IIDICLOFENAC SODIUM, ISOPROPYL ALCOHOLPureTek Corporation2e70d8e9-9678-2d51-e063-6294a90aca642025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633

Reported adverse events (FAERS/openFDA)#

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