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 46 of 68 · 1,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD303097a0-8eb0-3e1c-e063-6394a90afab32025-01-01WarningsExact identifier
unii: ND2M416302
Diclofenac DRDICLOFENACAdvanced Rx of Tennessee, LLCaf8a30fb-ead8-7e29-e053-2a95a90a040f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLCb3dbd981-453c-645f-e053-2a95a90aec3c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC0803345d-7811-bc21-e063-6394a90aa6612024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd424ab84-2aaa-38a9-e053-2a95a90adde92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCec06cca5-3436-10c8-e053-2995a90a4aeb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1896c84-b18a-d49d-e053-2995a90aaab32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7264-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf3d27ae6-1259-5375-e053-2995a90a572d2024-12-31WarningsExact identifier
application number: ANDA210986
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf187ae44-71be-a682-e053-2995a90a64262024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAdvanced Rx Pharmacy of Tennessee, LLCfc0e6a51-bec3-f7ee-e053-6394a90ada9a2024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCfc0e1950-d76f-75bc-e053-6294a90a8c122024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
unii: T5L8T28FGP
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
unii: ND2M416302
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCaf8a1392-67e8-8201-e053-2a95a90a0fce2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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