NDC 85534-0026-01 - Paroxetine

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
85534-0026
Requested NDC
85534-0026-01
Package NDCs from labels
85534-0026-0, 85534-0026-1, 85534-0026-2, 85534-0026-3, 85534-0026-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Paroxetine - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-06-26HUMAN 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 111 · 2,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.7d558598-6905-46da-8f34-668456c684112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738511
unii: X2ELS050D8
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.ee38b589-e646-4203-bea5-cc3744fe17c32026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738503
unii: X2ELS050D8
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738495
rxcui: 1738483
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.05ec70fd-4c65-495f-ba12-e8433a10b6552026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738495
unii: X2ELS050D8
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
ParoxetinePAROXETINEREMEDYREPACK INC.c002508e-f96c-413b-b232-5d55fceeffe02026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738483
unii: X2ELS050D8
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.88b4c469-19b3-44b9-a378-c7c3f4f436db2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738503
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.f52ca1fc-fbf7-4b2b-9e74-975c310b8ce62026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738483
unii: X2ELS050D8
ParoxetinePAROXETINEREMEDYREPACK INC.679e4b9b-0f7b-450a-aca7-1b448cccbeed2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077584
rxcui: 1738503
unii: X2ELS050D8
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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