FDA.reportPublic FDA data

NDC 76420-393 - 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
76420-393
Package NDCs from labels
76420-393-60, 76420-393-14, 76420-393-30, 76420-393-90, 76420-393-01
Manufacturer
ASCLEMED USA INC.
Effective date
2025-09-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium Delayed-release Tablets, USP 75 mgASCLEMED USA INC.2025-09-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-393-01Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1002
76420-393-14Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE142
76420-393-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
76420-393-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE602
76420-393-90Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

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 72 of 126 · 2,510 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077863
ndc (product): 16571-201
rxcui: 855926
rxcui: 855906
rxcui: 855664
spl id: 504b1904-033c-4fd8-92c9-41e31154f808
spl set id: 3330ea92-fc9d-4541-b378-be399b0995d3
unii: QTG126297Q
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLMicro Labs Limitedc61df58d-d6bb-4d3e-9ef8-60caa7d4e7622025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3a4f7301-aa1c-9064-e063-6294a90a6eb42025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPHOENIX RX LLC3a63e26f-27d7-9a25-e063-6294a90a55fe2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
unii: QTG126297Q
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
unii: 15FIX9V2JP
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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