FDA.reportPublic FDA data

NDC 68071-4859-01 - 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
68071-4859
Requested NDC
68071-4859-01
Package NDCs from labels
68071-4859-1, 68071-4859-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium Gel, 3%NuCare Pharmaceuticals,Inc.2024-06-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4859-12021-02-17C16284748780-1ba0f9c33-11c4-a910-e053-dadaa90a0b85Diclofenac Sodium Gel, 3%
68071-4859-12021-01-29C16284748780-1ba0f9c33-11c4-a910-e053-dadaa90a0b85Diclofenac Sodium Gel, 3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4859-1diclofenac sodium100 g in 1 BOXGEL1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4859DICLOFENAC SODIUM GEL [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240616_8721da56-0f8a-5903-e053-2991aa0a61b5.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 9 of 28 · 547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug325213a3-241c-18d2-e063-6394a90a40f72025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLNivagen Pharmaceuticals, Inc.2acf46ac-8ba8-444d-b421-19d5ad49644c2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions58063c26-86fe-4f03-97ef-51706e5f40542025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug37362eb4-db16-f4ad-e063-6394a90a42aa2025-12-13WarningsExact identifier
unii: QTG126297Q
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
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALSOLA Pharmaceuticalsc3f33952-44a8-71b2-e053-2a95a90abda22025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
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
unii: QTG126297Q
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATEASCLEMED USA INC.263f64d5-da3e-43cc-a651-2136f3b1f2ea2025-12-02WarningsExact identifier
unii: QTG126297Q
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
Diclofenac SodiumDICLOFENAC SODIUM TOPICALProficient Rx LP140a2c64-4996-4da3-b10f-1b8235ebde9d2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAlembic Pharmaceuticals Inc.30c3c3c5-b4f3-4321-ae25-b2c588ad05512025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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