FDA.reportPublic FDA data

NDC 52389-166-28 - Psoriasin Gel

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
52389-166
Requested NDC
52389-166-28
Package NDCs from labels
52389-166-21, 52389-166-28, 52389-166-01, 52389-166-56, 52389-166-42, 52389-166-43, 52389-166-57
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2026-06-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Psoriasin GelKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2026-06-09HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-166PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]13Legacy NDC20241106_a046878f-ffc7-417e-9145-5ccc176b4683.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Coal tarACTIVE INGREDIENTR533ESO2ECPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Coal tarACTIVE MOIETYR533ESO2ECPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Aloe vera leafINACTIVE INGREDIENTZY81Z83H0XPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Isopropyl alcoholINACTIVE INGREDIENTND2M416302PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

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 20 of 218 · 4,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559a9300-964e-ea9a-e063-6394a90a40162026-07-02WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt AirETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559a5f07-1557-c6d6-e063-6394a90a832f2026-07-02WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55242d92-04af-0224-e063-6394a90aee982026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer Watermelon ScentedALCOHOLFamily Dollar Stores, Inc.efe9989b-b729-439d-8489-3a100abcf8212026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer, Cucumber and Melon ScentedALCOHOLFamily Dollar Stores, Inc.dbd29c6e-fa01-49ad-a673-66b25f558ad42026-07-02WarningsExact identifier
unii: 3K9958V90M
Family Beauty Hydrating Hand Sanitizer, Coconut ScentedALCOHOLFamily Dollar Stores, Inc.35ce4c48-f260-4306-a886-add12820ac782026-07-02WarningsExact identifier
unii: 3K9958V90M
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
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
American Red Cross IPA 50% 6ozAMERICAN RED CROSS IPA 50% 6OZTSM BRANDS LLC29195bac-b096-ab8d-e063-6394a90a424a2026-07-01WarningsExact identifier
unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl AlcoholAMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAYMY IMPORTS USA LLC2929d580-cfff-e2b6-e063-6394a90a79aa2026-07-01WarningsExact identifier
unii: ND2M416302
Medi Fect Antiseptic Hand WashETHYL ALCOHOLMedical Chemical Corporationdc397d9c-9c12-41e5-ab7f-196fcad5bf972026-07-01WarningsExact identifier
unii: 3K9958V90M
AloeSafe Antiseptic Hand SanitizerETHYL ALCOHOLMedical Chemical Corporation950f012e-7908-523c-e053-2995a90afa6b2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Berry BlissALCOHOLBath & Body Works, Inc.55935d41-ce7a-796a-e063-6294a90a6ba22026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Tangerine TwirlALCOHOLBath & Body Works, Inc.55933da8-dfbc-6877-e063-6394a90abb7f2026-07-01WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Watermelon WhirlALCOHOLBath & Body Works, Inc.559364cc-2b55-9628-e063-6394a90ac8e62026-07-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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