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 53 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
unii: T5L8T28FGP
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
unii: T5L8T28FGP
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
unii: T5L8T28FGP
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
unii: T5L8T28FGP
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
unii: T5L8T28FGP
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
unii: ND2M416302
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions70156824-e5dd-42b1-9b4f-a49acb28d3162024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
unii: ND2M416302
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc2e3e6de9-7e07-4df3-9fea-ac50ddcde8402024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf5b4e308-c156-4865-95ee-1a8e267535ba2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions4500bf3c-394b-4397-8751-8dac2097fc412024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.22f4b8aa-902f-a860-e063-6394a90ada262024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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