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 28 of 218 · 4,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cf590a-2a74-d8fe-e063-6294a90a64382026-06-21WarningsExact identifier
unii: 3K9958V90M
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
B-Pure Moisturizing Hand Sanitizer Fireside Vanilla ScentedALCOHOLFourstar Group USA, Inc.d662c090-c664-4422-890d-601181a6ee092026-06-18WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Maple ScentedALCOHOLFourstar Group USA, Inc.5f0db090-5a95-405d-8db8-f47556f9779e2026-06-18WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Warm Cashmere ScentedALCOHOLFourstar Group USA, Inc.66e51449-78ef-42ef-a8e5-19fdcaac15d82026-06-18WarningsExact identifier
unii: 3K9958V90M
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
B-Pure Moisturizing Hand Sanitizer Evergreen Cashmere ScentedALCOHOLFourstar Group USA, Inc.279b3998-2433-4c5a-92b0-c67daf08b65a2026-06-18WarningsExact identifier
unii: 3K9958V90M
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
unii: ND2M416302
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
unii: 3K9958V90M
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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