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 67 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.d4b81a74-6926-4715-bf90-aec026cff2b42022-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af49488d-5aeb-e3d9-e053-2a95a90afb042022-08-31WarningsExact identifier
unii: ND2M416302
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af498f92-6029-46b9-e053-2995a90a1c6d2022-08-31WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.b162d65d-b105-4a68-90bb-316b9686267b2022-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMProficient Rx LP67e384c6-8476-4aad-b967-241335538d562022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LPafce2de2-0c59-4191-bf79-782ca31e427d2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLProficient Rx LP33f7db0b-f049-4d2e-abf5-4db97222e1752022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions3a520306-fe3e-4830-963f-04b080db3abc2022-06-01Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
good sense arthritis painDICLOFENAC SODIUMProficient Rx LP67eacd91-8378-47e7-9bad-1e7b685aa9d42022-06-01WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP9eeb2aef-3eb1-4583-8180-d480deb3651c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP947c0c1f-3573-4f69-ab82-8b50c43e55862022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
unii: ND2M416302
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC047985ea-f768-4f9a-bfe3-0acf40a4781d2022-02-15WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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