FDA.reportPublic FDA data

NDC 68071-3665-01 - 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
68071-3665
Requested NDC
68071-3665-01
Package NDCs from labels
68071-3665-1, 68071-3665-01
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3665-1Diclofenac Sodium1 in 1 CARTONGEL11
68071-3665-1Diclofenac Sodium100 g in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3665DICLOFENAC SODIUM GEL [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240820_200c2800-a703-e138-e063-6394a90acc09.zip

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 42 of 68 · 1,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMINNOVUS PHARMACEUTICALS, INC.ad9d2c28-21bc-4f81-9c90-cce6a96d976a2025-03-25WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
unii: ND2M416302
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPreferred Pharmaceuticals Inc.6d5243ae-4a1a-4583-9337-085520e1f14a2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.c933eaad-ba53-4130-90db-a66f89dfc29f2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCipla USA Inc.daf52f5a-1bb7-4808-ab98-483ab9e8cfa02025-03-11WarningsExact identifier
application number: ANDA209903
rxcui: 855633
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAlembic Pharmaceuticals Limited048ede6a-b7cd-4100-8979-519bd44906c82025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.31b56330-6870-48b7-a8c4-0639e0766b252025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Limited11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
VennGel IIDICLOFENAC SODIUM, ISOPROPYL ALCOHOLPureTek Corporation2e70d8e9-9678-2d51-e063-6294a90aca642025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
unii: ND2M416302
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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