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 33 of 218 · 4,360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care MIDNIGHT MUSK HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4a9d80b7-619a-4eba-9535-ea7605b6cd712026-05-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.52db71d5-42fc-c3b6-e063-6394a90aea152026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Creamy Macadamia ScentedALCOHOLFourstar Group USA, Inc.e59282f1-82f1-465e-9db3-f207177151e62026-05-28WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLHubei Fanjian Medical Product Co.,Ltd9b4014a3-6296-4628-9cc6-b8d4ef4a25f32026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedALCOHOLFourstar Group USA, Inc.e145d190-5290-47d9-9961-e35f746e6b5a2026-05-28WarningsExact identifier
unii: 3K9958V90M
Alcohol Cleansing WipeALCOHOLHubei Fanjian Medical Product Co.,Ltdf278a911-ac4e-6868-e053-2a95a90a2ee32026-05-28WarningsExact identifier
unii: 3K9958V90M
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Warm DriftwoodALCOHOLMy Imports Usa, LLCb8457e01-e95f-4507-ac83-3c537c4677392026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer White MuskALCOHOLMy Imports Usa, LLCee41e0d2-7109-4423-82db-2c751de6a5d82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Caramel CinnamonALCOHOLMy Imports Usa, LLCa77a074b-662a-4d40-a73e-6fe215d2c22f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Bergamot WaterALCOHOLMy Imports Usa, LLC4e709d1b-b902-4c40-b156-70b3e0f31cc22026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Tropical MelonALCOHOLMy Imports Usa, LLCb12baf08-4a3d-4e5a-9720-a9d2174a01242026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Champagne AppleALCOHOLMy Imports Usa, LLC84b2359f-3446-4b2a-abc5-6503209bc06f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sunset AmberALCOHOLMy Imports Usa, LLC004452a0-7e99-4487-8311-6e428e3c0f262026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Honey Fresh BloomALCOHOLMy Imports Usa, LLC3a64b15c-c8dc-471c-9e2e-b144d9e13cc52026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Soft CottonALCOHOLMy Imports Usa, LLCadd6c1a8-5ae7-4350-b4f5-e5222db854b12026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sweet Mint SplashALCOHOLMy Imports Usa, LLC1d1b0435-f6d8-4fe2-83f0-b6943ce924f82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Raspberry LemonadeALCOHOLMy Imports Usa, LLC9a052668-16cb-4d8e-9964-84d1516baed32026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Golden Honey CitrusALCOHOLMy Imports Usa, LLC66788240-f39b-455f-9aee-08715dbe0eab2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sugared CoconutALCOHOLMy Imports Usa, LLC2d52e9de-e850-4842-899e-1f8cc721154d2026-05-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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