FDA.reportPublic FDA data

NDC 68391-871 - berkley and jensen arthritis pain

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
68391-871
Package NDCs from labels
68391-871-02, 68391-871-03, 68391-871-00
Manufacturer
BJWC
Effective date
2023-07-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
berkley and jensen arthritis pain - BJWCBJWC2023-07-26HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-871-00berkley and jensen arthritis pain2 in 1 CARTONGEL10 mg in 1g3
68391-871-02berkley and jensen arthritis pain1 in 1 CARTONGEL10 mg in 1g3
68391-871-02berkley and jensen arthritis pain50 g in 1 TUBEGEL50 g10 mg in 1g3
68391-871-03berkley and jensen arthritis pain150 g in 1 TUBEGEL300 g10 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-871BERKLEY AND JENSEN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [BJWC]3Unmatched20231130_441cf367-b293-47e8-a8fb-32e3314be7de.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 66 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LeflunicloLEFLUNOMIDE AND DICLOFENAC SODIUM GELV2 Pharma, LLC91d62919-c4bb-4dd0-af23-c5183bc53d002023-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
Crcle Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL 1%Innovus Pharmaceuticals Inc.b373c202-5795-418f-989c-1ec5837145af2023-03-24WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products LLC94422b85-28ed-477f-853a-71d1d6cf17d52023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP73a46413-ecbc-4453-814d-bec955b375d22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPb41335b6-859f-4568-84d2-0d0408415a4e2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesale141b6693-6d6c-45c6-9b82-ee1afcfca12a2023-01-27WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Proficient Rx LPb4694451-a13d-484e-92c4-c03a6fcbb5112023-01-01WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALProficient Rx LP90b25b9b-3930-48af-b139-d24f2fccfcdc2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb98d921a-2ee7-4770-ac21-d845b2dcc11c2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMP & L Development, LLC2596645a-b736-4d3c-82a0-00713f1b6fbd2022-12-15WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMAltaire Pharmaceuticals Inc.5372866a-dab3-45c8-8c2a-755ca36c17912022-10-28Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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