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 47 of 68 · 1,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
unii: ND2M416302
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
unii: T5L8T28FGP
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
unii: T5L8T28FGP
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf0f12204-2948-1357-e053-2995a90ae50a2024-12-19WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLNew Pride Corpf0f223b9-fa98-f118-e053-2a95a90a1ac72024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Products3c32b817-39fa-4801-9f40-6073b3e188552024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 99% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsd196bef3-625a-b7d5-e053-2995a90afe6c2024-12-19WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLHome Smart Productscfe4fca2-bb20-4ab3-b304-32d9ba0451f62024-12-19WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHome Smart Products9cc0767c-b9aa-42c1-b183-a35f2560942b2024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf159051c-27de-52a9-e053-2995a90aeb722024-12-19WarningsExact identifier
unii: ND2M416302
91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf15a6843-78bd-223c-e053-2a95a90a20332024-12-19WarningsExact identifier
unii: ND2M416302
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf158ad51-b772-257f-e053-2a95a90a55582024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsce735a5f-0502-44ca-b2d6-db97ad0c01cb2024-12-19WarningsExact identifier
unii: ND2M416302
AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORT USA INC8e52e75f-717a-4829-b1aa-f35cf1981af82024-12-19WarningsExact identifier
unii: ND2M416302
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHome Smart Productsd1601184-c38c-79eb-e053-2a95a90aba502024-12-19WarningsExact identifier
unii: ND2M416302
germstar Original unscentedISOPROPYL ALCOHOLSoaptronic, LLCda14d588-a9f7-4796-a532-20156afc100f2024-12-19WarningsExact identifier
unii: ND2M416302
Diclofenac sodiumDICLOFENAC SODIUMQuality Care Products, LLC3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products, LLC12e1f808-9f24-4f6d-b5bc-12ce0059ab7a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
unii: QTG126297Q
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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