FDA.reportPublic FDA data

NDC 85534-0089-00 - 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
85534-0089
Requested NDC
85534-0089-00
Package NDCs from labels
85534-0089-0, 85534-0089-00
Manufacturer
HAWAII REPACK, INC
Effective date
2026-07-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DICLOFENAC SODIUM - HAWAII REPACK, INCHAWAII REPACK, INC2026-07-12HUMAN PRESCRIPTION DRUG LABEL

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 2 of 28 · 547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.ddd2278b-70be-41ca-8a84-e3fe0f1a15612026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Diclofenac sodiumDICLOFENAC SODIUMCVS Pharmacy591cc2ed-e667-4779-a426-8a2e6f8735732026-07-22WarningsExact identifier
unii: QTG126297Q
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DICLOFENAC SODIUMDICLOFENAC SODIUMAurobindo Pharma Limitedd9b6f1d0-1710-46fb-8ea4-80b3ca60a5752026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMHAWAII REPACK, INCea113a58-c7ed-4768-9777-93d9b166dfbe2026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208301
ndc (package): 85534-0089-0
ndc (product): 85534-0089
ndc11 (package): 85534008900
rxcui: 855642
spl id: 566cbcc2-290d-9b1f-e063-6294a90a9c2e
spl set id: ea113a58-c7ed-4768-9777-93d9b166dfbe
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM 1%Sportpharm LLC391d9d0b-74b7-4359-aea0-d3bb8c8d3cd12026-07-10WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packaging63c00b50-06d3-4659-81cf-be4516429e812026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.6e6a6f98-5517-4f67-9a6a-71019ba2d7732026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.71a823c4-9c88-474d-b525-276f9e7808aa2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.09643e65-f301-4891-96f4-d78bf3621e232026-07-02WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMAmerican Health Packagingdbb1489d-b690-4e53-905d-7fb07ad263b32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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