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 65 of 69 · 1,371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
berkley and jensen arthritis painDICLOFENAC SODIUMBJWC441cf367-b293-47e8-a8fb-32e3314be7de2023-07-26WarningsExact identifier
application number: ANDA211253
ndc (package): 68391-205-00
ndc (package): 68391-871-03
ndc (package): 68391-871-02
ndc (package): 68391-871-00
ndc (product): 68391-205
rxcui: 855633
spl id: f8497dc3-9d28-4ad9-8770-eb36ed0563cb
spl set id: 441cf367-b293-47e8-a8fb-32e3314be7de
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepack16853c78-493a-4b8b-87b9-97dc927e1c8e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Ammonium CausticumAMMONIUM CAUSTICUMHahnemann Laboratories, INC.00653070-bf09-78d9-e063-6394a90a0bcf2023-07-13Exact identifier
unii: 5138Q19F1X
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Prevantics Maxi SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.93ca3c07-40b4-3a91-e053-2995a90a0afd2023-06-30WarningsExact identifier
unii: ND2M416302
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENACProficient Rx LPf4da38af-c5bd-4d4a-a6f3-c2933f2238092023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACBryant Ranch Prepacke5f8284a-1aa9-4a36-a6ad-fa153c613f342023-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
good sense arthritis painDICLOFENAC SODIUML. Perrigo Company7b32b9e4-6502-4fa3-808f-3bef9525b6a12023-05-10WarningsExact identifier
application number: ANDA211253
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENACA-S Medication Solutions58178f0d-3960-48e3-91ba-150f691be2412023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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