FDA.reportPublic FDA data

NDC 62379-401-01 - 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
62379-401
Requested NDC
62379-401-01
Package NDCs from labels
62379-401-01, 62379-401-02, 62379-401-03, 62379-401-04
Manufacturer
Simple Diagnostics
Effective date
2024-03-19
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% - Simple DiagnosticsSimple Diagnostics2024-03-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62379-401-01DICLOFENAC SODIUM100 g in 1 TUBEGEL1008
62379-401-02DICLOFENAC SODIUM1 in 1 CARTONGEL18
62379-401-03DICLOFENAC SODIUM150 g in 1 TUBEGEL1508
62379-401-04DICLOFENAC SODIUM1 in 1 CARTONGEL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62379-401DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [SIMPLE DIAGNOSTICS]8Current NDC, 4 package rows20240321_13925cd5-e121-80d2-e063-6394a90af9a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62379-401-01GM - Gram62379-401ef674c44-7b6c-4b43-ab1a-aaba35743bfc12024-04-05
62379-401-03GM - Gram62379-40123876cdc-9b0b-492d-bf77-51c1b60e6bfc12024-04-05

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 45 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXa5b33bf7-8113-9c54-e053-2995a90a79d82025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Inc.02e90e33-384f-4e29-b508-2503def222142025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.62edf474-9c16-d535-e053-2991aa0a4a092025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
unii: T5L8T28FGP
Alcohol CleansingISOPROPYL ALCOHOLCMC Group Inc.e3985ef1-503a-4193-a5b5-7910aefa78142025-01-13WarningsExact identifier
unii: ND2M416302
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
unii: ND2M416302
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALPreferred Pharmaceuticals Inc.dbcd42cf-d44a-4d47-9149-66ffcf9a05872025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.81bfeada-6589-4528-bea5-059ab0fabb432025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
unii: ND2M416302
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCfd467c1a-6463-4d92-9960-3e308c733edb2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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