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 52 of 217 · 4,340 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Tattoo numbing creamHEMP SEED OILGuangzhou Mizi Biotechnology Co., LTD.4cd03bed-99be-e4e8-e063-6294a90a94542026-03-12WarningsExact identifier
unii: ZY81Z83H0X
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
unii: 3K9958V90M
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders 2in1 Classic CleanPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company65a4082f-227b-49bf-b88c-b1c651ed13a02026-03-12WarningsExact identifier
application number: M032
Head and Shoulders Green Apple 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc036c9a6-6507-4037-b97b-1b015dd950c12026-03-12WarningsExact identifier
application number: M032
Limited Edition Hand Sanitizer Cashmere SkinALCOHOLScent Theory Products LLC4cdc4282-eb49-3120-e063-6294a90a2d612026-03-12WarningsExact identifier
unii: 3K9958V90M
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
unii: ND2M416302
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands, LLCca7c6243-dc7f-40c4-8b51-ec9a7c1f14f52026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUpLift Brands, LLCba4be8c2-00ce-48e6-a83c-6c1bde3c3aa42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLUpLift Brands LLCf6608379-051f-4151-bcf7-ecd87070f4392026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCa1954926-35f6-439e-863f-29351013e5542026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands LLCdd569334-0280-49d6-afcf-0c49ed316cb92026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCef02b350-1a37-42d4-8eaa-38a2de5e41eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCbf53255d-18d7-4672-8139-bacc5cb1a2e62026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLC03ed8a06-33aa-4893-824c-a3843962de3d2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand Sanitizer with AloeETHYL ALCOHOLUpLift Brands, LLC62cfbf46-9c12-487f-81d9-a1f839402ec42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ETHYL ALCOHOLETHYL ALCOHOLUpLift Brands, LLC42b1aff5-d788-0d46-e063-6294a90a02d32026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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