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 11 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepackb28e4a68-f396-4c1a-ba38-6a972906b4d02026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALASCLEMED USA INC.fd94964b-167b-41b7-a612-8febe9ae05112026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.96f8c42c-db34-43b0-a891-33dd8e39e74f2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWinCo Foods, LLCc22a5fc3-78f5-4660-96a6-479ca6f776022026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLWinCo Foods, LLC2b48ee19-8f0c-4b36-855d-7909dde5c8712026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e947653c-6789-4c15-82c9-4b1402f6d6ac2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.ed1b5ec7-2812-4a81-90d1-953baa0b0ec82026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurolife Pharma LLCdfb7afdf-5c05-4487-9044-936e151e5ba62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.5d0a4b41-afbf-45e7-bb1c-587d72314ee02026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.15b280a1-4964-4636-833b-3db44044d2892026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACPreferred Pharmaceuticals Inc.937e9ba5-cdad-4e72-a77a-bad699e1b2362026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Medt PadISOPROPYL ALCOHOLCarelife (USA) Inc.74a05c37-becd-4c93-96cb-79f69add5e4d2026-04-02WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals, Inc.4a3549e0-1e2d-42bf-b82c-1e62837ba2e42026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e042e64c-5f18-4483-bcbd-dfd9b08a81cf2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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