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 43 of 67 · 1,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
unii: ND2M416302
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
unii: T5L8T28FGP
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.0d1d19e5-4ffe-af95-e063-6394a90a7abf2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPd70fcd8e-a72b-41ef-ac26-e0f2f279f0622025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.74169b2d-ac56-4757-86c4-cdcfcd5f4eb52025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMCoupler LLC2ce0741a-7bc7-8aec-e063-6294a90ae9ef2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackd6671b66-00ad-4949-b51a-36e1130b1cb52025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack49013aad-475c-4efb-84c6-15a5d4664fbf2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.762b7ef4-166c-43b8-9acd-2b9e7fa0bf362025-01-28WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
unii: ND2M416302
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: T5L8T28FGP
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMDirect_Rxf80b0b95-f4da-2d6c-e053-6294a90acf922025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxfce9b3eb-ae79-a090-e053-6294a90ad20e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMDirect_Rx0c41977f-8dad-1d26-e063-6294a90a9b222025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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