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 54 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: T5L8T28FGP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: T5L8T28FGP
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLembecta Medical II, LLCe9576c62-6b6e-4c51-a162-0f93f7ffd7dd2024-09-13WarningsExact identifier
unii: ND2M416302
Gencare-Arthritis Pain ReliefDICLOFENAC SODIUMPioneer Life Sciences, LLC4b1438bb-8591-4237-abcb-91491f34ad8f2024-09-10WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
ammonia inhalantsINHALANTEpic Medical Supply Corp20e849e5-8517-b9fd-e063-6394a90a0d232024-09-03WarningsExact identifier
unii: 5138Q19F1X
Isopropyl AlcoholISOPROPYL ALCOHOLWildman Business Group1fd15c0f-7119-0712-e063-6294a90a96252024-09-01WarningsExact identifier
unii: ND2M416302
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMHarris Teeter17ed520d-bfbe-4a33-e063-6394a90aa0f62024-08-30WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.200c2800-a703-e138-e063-6394a90acc092024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2bebda5e-227e-4a49-80e3-191cfc8052952024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
unii: T5L8T28FGP
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions203f96bb-ae63-475c-b7a6-03c0dbc435972024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack12cce748-a7de-4b1e-9603-b5c2ce12d5312024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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