FDA.reportPublic FDA data

NDC 68071-3483-01 - 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
68071-3483
Requested NDC
68071-3483-01
Package NDCs from labels
68071-3483-1, 68071-3483-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-09
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% (NSAID) - arthritis pain relieverNuCare Pharmaceuticals,Inc.2024-07-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3483-1DICLOFENAC SODIUM1 in 1 CARTONGEL13
68071-3483-1DICLOFENAC SODIUM100 g in 1 TUBEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3483DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20240710_0326ea5b-3e1a-dee2-e063-6294a90a13b8.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 26 of 68 · 1,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dukal/Fisher Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC43d2909a-f7ad-1426-e063-6394a90ab52c2025-12-12WarningsExact identifier
unii: ND2M416302
ALCOH-WIPEISOPROPYL ALCOHOLVeltek Associates, Inc.343ba13e-7f90-5dab-e063-6294a90a56ae2025-12-10WarningsExact identifier
unii: ND2M416302
PHARMA CARE Pro Sterile Prep Swabstick 70% IPAISOPROPYL ALCOHOLEnviro Specialty Chemicals Ince4360435-266b-4eea-8032-69693c0716482025-12-10WarningsExact identifier
unii: ND2M416302
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
unii: ND2M416302
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
UP AND UP ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTarget Corporation3a9b32af-a3cd-496b-9698-0421443e03852025-12-08WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALSOLA Pharmaceuticalsc3f33952-44a8-71b2-e053-2a95a90abda22025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs453b0e9c-8676-99fa-e063-6394a90a88a12025-12-08WarningsExact identifier
unii: 5138Q19F1X
Snap Labs 20-Count Ammonia InhalantsAMMONIA INHALANTSBrined LLC d/b/a Snap Labs4575d816-b08f-13fb-e063-6294a90af3ba2025-12-08WarningsExact identifier
unii: 5138Q19F1X
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fbb53e-b547-0615-e053-2995a90a51512025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fb4069-b926-266b-e053-2995a90acab92025-12-03WarningsExact identifier
unii: ND2M416302
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATEASCLEMED USA INC.263f64d5-da3e-43cc-a651-2136f3b1f2ea2025-12-02WarningsExact identifier
unii: QTG126297Q
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
unii: ND2M416302
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
unii: T5L8T28FGP
Diclofenac SodiumDICLOFENAC SODIUM TOPICALProficient Rx LP140a2c64-4996-4da3-b10f-1b8235ebde9d2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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