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 12 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Preferred Pharmaceuticals, Inc.aee20924-79ab-400e-b9b6-4189789146542026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
unii: ND2M416302
arthritis pain relievingDICLOFENAC SODIUMWalgreen Company0da5d1d0-d8a4-4509-a098-e9c36d2824742026-03-31WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Isopro First AidISOPROPYL ALCOHOLWater-Jel Technologiesf38563f5-ee54-4979-9157-4bf8fd60daab2026-03-31WarningsExact identifier
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e404989-89d0-b189-e063-6394a90a8caa2026-03-30WarningsExact identifier
unii: ND2M416302
MedPride Sterile Prep PadsISOPROPYL ALCOHOLShield Line LLC31de24d8-b70e-47f1-8946-6bd9fb16b5d52026-03-30WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMREMEDYREPACK INC.d349d286-b462-4f8f-aa39-6173653175d62026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
unii: T5L8T28FGP
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMST. MARY'S MEDICAL PARK PHARMACY4ddd7e34-e5f4-8f05-e063-6294a90a70aa2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLSportpharm LLC0d6509a1-7af8-473b-8951-c194392743792026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
THESIS PHARMACY Alcohol Prep PadISOPROPYL ALCOHOLCarelife (USA) Inc.841d8b55-6383-4e02-9047-7b01e9f20a542026-03-24WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.663a3dbc-a631-4046-8852-ec619c41c81d2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Diclofenac Sodium Topical SolutionDICLOFENAC SODIUM TOPICAL SOLUTIONDirect_Rx223f0fb4-2006-c2dd-e063-6394a90a563a2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRxd5f215d4-9aa3-2ecf-e053-2995a90a2e892026-03-17Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxe82e4d34-bdaa-b950-e053-2995a90a29f12026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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