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 5 of 28 · 547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENACPreferred Pharmaceuticals Inc.937e9ba5-cdad-4e72-a77a-bad699e1b2362026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals, Inc.4a3549e0-1e2d-42bf-b82c-1e62837ba2e42026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e042e64c-5f18-4483-bcbd-dfd9b08a81cf2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Preferred Pharmaceuticals, Inc.aee20924-79ab-400e-b9b6-4189789146542026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
arthritis pain relievingDICLOFENAC SODIUMWalgreen Company0da5d1d0-d8a4-4509-a098-e9c36d2824742026-03-31WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMREMEDYREPACK INC.d349d286-b462-4f8f-aa39-6173653175d62026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMST. MARY'S MEDICAL PARK PHARMACY4ddd7e34-e5f4-8f05-e063-6294a90a70aa2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLSportpharm LLC0d6509a1-7af8-473b-8951-c194392743792026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: YSE9PPT4TH
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.663a3dbc-a631-4046-8852-ec619c41c81d2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Diclofenac Sodium Topical SolutionDICLOFENAC SODIUM TOPICAL SOLUTIONDirect_Rx223f0fb4-2006-c2dd-e063-6394a90a563a2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRxd5f215d4-9aa3-2ecf-e053-2995a90a2e892026-03-17Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxe82e4d34-bdaa-b950-e053-2995a90a29f12026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208301
rxcui: 855642
unii: QTG126297Q
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxfc0c9cfe-998b-d22a-e053-6294a90afa422026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMDirect_Rx946b3799-2d56-12a5-e053-2a95a90aeba02026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 855642
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackde4c02a5-87e8-42f5-a9ff-f409ff9e6d622026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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