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 55 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
unii: ND2M416302
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2b7462e6-62dc-4b08-9fbf-5858e356a7a82024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMEXELAN PHARMACEUTICALS INC.be25c19e-cbea-4f87-a581-9f0d350e5adf2024-08-02WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b82024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.4b44ac98-225c-1739-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.abacf60f-0410-e6da-e053-2995a90a413c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Ultra Prep Alcohol Prep PadsISOPROPYL ALCOHOLQuality Medical Products USA, Inc.f81a63dd-a699-459f-ab52-f63a6550b6802024-07-16WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC78873f83-cea9-44d4-8ad4-8cb9257e5c7f2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1d4d6370-2b45-fa6d-e063-6294a90a4a672024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%NuCare Pharmaceuticals,Inc.0326ea5b-3e1a-dee2-e063-6294a90a13b82024-07-09WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC81e964ff-6622-4054-bf01-6ed6eef6778f2024-07-06WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
unii: ND2M416302
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP898558e7-17f8-40cd-9dfc-67ddd64a5a422024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMKROGER COMPANY15e59aac-a642-91e4-e063-6294a90a11752024-06-28WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1be247b8-dafd-ddf9-e063-6294a90aa9e12024-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production(Xiamen) Co.,Ltdd8842561-f61e-4cac-80d6-001e5369f0d12024-06-25WarningsExact identifier
unii: ND2M416302
Curist Arthritis ReliefDICLOFENAC SODIUMLittle Pharma, Inc.e638a98e-e6d7-36ed-e053-2995a90af2ca2024-06-21WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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