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 48 of 217 · 4,340 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giant EagleALCOHOLApollo Health and Beauty Care419846a1-8d22-16f0-e063-6394a90a6bdd2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance FreeALCOHOLGOJO Industries, Inc.4e06bb4a-e1a5-8c79-e063-6294a90a293c2026-03-27WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer be BlissfulALCOHOLGOJO Industries, Inc.cebd0adb-dc26-407f-a290-418e0e206aea2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Fig ScentedALCOHOLFourstar Group USA, Inc.b66cd8a7-98ea-43b0-a92b-7d1da15f50142026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Cherry ScentedALCOHOLFourstar Group USA, Inc.290674c5-1622-451e-abd6-b586117827c32026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Vanilla Honey ScentedALCOHOLFourstar Group USA, Inc.f2eb0f80-083e-478a-a8df-0d2bb85901ad2026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Peachy Cherry Bliss ScentedALCOHOLFourstar Group USA, Inc.835a6a4c-1582-46fd-b5c3-4b79dbe11d502026-03-27WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand SanitizerSugared Strawberry ScentedALCOHOLFourstar Group USA, Inc.15e732fe-5c4b-4f3a-9dd5-a4f7015f75422026-03-27WarningsExact identifier
unii: 3K9958V90M
Tio Nacho Anti-DandruffSALICYLIC ACIDGenomma Lab USAc3c92b35-4955-4985-9a1d-8756c1b2131c2026-03-27WarningsExact identifier
application number: M032
IsagelALCOHOLColoplast Corp5be93a24-c644-4e6b-a600-87f0a5a09e5c2026-03-27WarningsExact identifier
unii: 3K9958V90M
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepack790a9ec0-eb61-4148-86e9-91439e4dce892026-03-27WarningsExact identifier
unii: 9E8X80D2L0
Suave Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONERSuave Brands Co., LLC41d9cfec-6d14-f620-e063-6294a90a078d2026-03-26WarningsExact identifier
application number: M032
Suave Anti dandruff Coconut MoistureANTI DANDRUFF SHAMPOOSuave Brands Co., LLC41da3d90-4845-0d8f-e063-6294a90aede12026-03-26WarningsExact identifier
application number: M032
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
Suave Men 2 IN1 Scalp DefenseANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC42517082-4d0a-90a3-e063-6294a90a59272026-03-26WarningsExact identifier
application number: M032
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
application number: M032
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
unii: 3K9958V90M
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
unii: 3K9958V90M
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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