FDA.reportPublic FDA data

NDC 70518-2574-02 - 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
70518-2574
Requested NDC
70518-2574-02
Package NDCs from labels
70518-2574-0, 70518-2574-2, 70518-2574-1, 70518-2574-3, 70518-2574-4, 70518-2574-02
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Paroxetine - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-2574-02023-03-10These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-02023-03-10These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-03-10These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-03-10These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-02023-01-30These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-02023-01-30These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-01-30These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-01-30These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2574-0Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011
70518-2574-1Paroxetine30 in 1 BOXTABLET, FILM COATED3011
70518-2574-2Paroxetine1 in 1 POUCHTABLET, FILM COATED111
70518-2574-3Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3011
70518-2574-4Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2574PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 5 package rows20250321_f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6.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 1 of 113 · 2,242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEApotex Corp087ff0d3-1761-47ea-a8c1-7c4cb679af972026-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X2ELS050D8
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
ParoxetinePAROXETINECoupler LLC598ece4d-0ac4-993b-e063-6294a90a1d342026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738511
unii: X2ELS050D8
ParoxetinePAROXETINECoupler LLC598efb76-93ef-f7de-e063-6394a90a632e2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738503
unii: X2ELS050D8
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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: B697894SGQ
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.7d558598-6905-46da-8f34-668456c684112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738511
unii: X2ELS050D8
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.ee38b589-e646-4203-bea5-cc3744fe17c32026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738503
unii: X2ELS050D8

Reported adverse events (FAERS/openFDA)#

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