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 16 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.06862cf2-9537-6661-e063-6294a90a20842026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
unii: T5L8T28FGP
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack03c4f06f-6a49-4404-bf3b-0aafa33c81ef2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLTopco Associates LLC9fbded5f-8dc1-4134-a711-48d1a581d8742026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCad1ef2ea-bfc3-4a8a-acd2-55e7f52813d42026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Universal ISOPROPYL Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC0c76f14b-9a0c-4573-96f2-cd4080eb99e62026-02-10WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLWalgreen Co.fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc2026-02-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLHy-Vee, Inc.4bbce274-1e62-0c6a-e063-6394a90af92f2026-02-10WarningsExact identifier
unii: ND2M416302
Diclofenac sodiumDICLOFENAC SODIUMRugby Laboratories95f3c70c-eded-4d24-b9b0-cfa0b7902d6e2026-02-10WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Sportpharm LLCa133d18e-981d-43b7-bef1-7869f7c7d9a72026-02-09WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6aab6c1f-9b02-4101-b7c8-ab7a557043202026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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