Psoriasin Gel

Product NDC
52389-166
11-digit product format
523890166
Labeler code
52389
Product ID
52389-166_ebf1fc75-1cd9-92fa-e053-2995a90a98ab
Type
HUMAN OTC DRUG
Nonproprietary name
Coal Tar Topical Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Alva-Amco Pharmacal Companies, Inc.
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1996-02-18
Marketing end
0000-00-00
Substance
COAL TAR
Active strength
13 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52389-166DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-01DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-21DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-42DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-43DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-56DDiscontinued by firm2026-10-05
excluded packagepackage52389-16652389-166-57DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0552389-166-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0552389-166-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0552389-166-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0552389-166-43d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0552389-166-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2652389-166-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2652389-166-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3152389-166-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3152389-166-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2852389-166-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2852389-166-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2152389-166-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2152389-166-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1052389-166-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1052389-166-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3152389-166-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3152389-166-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2052389-166-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2052389-166-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1052389-166-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1052389-166-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0852389-166-42ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0852389-166-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0352389-166-42367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0352389-166-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0952389-166-42557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0952389-166-21557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

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

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 4 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact identifier
application number: M032
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
application number: M032
5% Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.5278c9c2-4bce-fed4-e063-6394a90a7f332026-05-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.527902b1-2018-4546-e063-6394a90a70522026-05-23WarningsExact identifier
application number: M032
VeraRoot Minoxidil Topical SolutionVERAROOT MINOXIDIL TOPICAL SOLUTIONShenzhen Xinxin Yunhai Technology Co., Ltd.52794d53-43ba-98ea-e063-6394a90a80a92026-05-23WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc521c263e-d29c-2564-e063-6394a90a2e1d2026-05-18WarningsExact identifier
application number: M032
Matrix Biolage Scalp Sync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Incea6fb9ff-8895-4754-9fd7-d24c235f01322026-05-15WarningsExact identifier
application number: M032
Simply Clean DandruffPYRITHIONE ZINCAldi, Inc6db037d4-c781-4cee-a4d5-52a93eccd55f2026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCAldi, Incb27d1453-d825-43ac-8a44-d7a5015ab9772026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Incd6a704df-edd8-4960-a088-246519e2aecf2026-05-12WarningsExact identifier
application number: M032
Kopa Haiku Seborrheic Dermatitis Face CreamSALICYLIC ACID 0.5% AND ZINC PYRITHIONE 0.25%Trovina Co. Ltd483450d2-e38b-56ec-e063-6394a90acb5b2026-05-10WarningsExact identifier
application number: M032
Mens SportPYRITHIONE ZINCApollo Health and Beauty Care1d1203ea-9994-31bb-e063-6394a90a9ec82026-05-08WarningsExact identifier
application number: M032
Classic CleanSHAMPOOApollo Health and Beauty Carefa684d69-771a-d3d4-e053-6294a90a13442026-05-08WarningsExact identifier
application number: M032
CVS GoldSELENIUM SULFIDEApollo Health and Beauty Care1d12ca6a-2734-0534-e063-6294a90a27062026-05-08WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCApollo Health and Beauty Care0a4ab6fa-bf74-fe6e-e063-6394a90aa6fc2026-05-08WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Total Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5126db42-4fd3-319e-e063-6394a90aab3f2026-05-06WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDCISNE GROUP LLC512abbb6-ea6a-70b1-e063-6294a90a2a7c2026-05-06WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec1a09dc-7fb6-6d89-e053-2a95a90a48412026-05-05WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDGuangzhou Pallas Cosmetics Co.,Ltd.51178cb9-f83f-2459-e063-6394a90a3f1e2026-05-05WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-166-01523890166011 TUBE in 1 CARTON (52389-166-01) > 28.35 g in 1 TUBE (52389-166-28) 1 tube2013-03-150000-00-00NoNoCurrent
52389-166-43523890166432 TUBE in 1 BOX (52389-166-43) > 21.25 g in 1 TUBE2 tube2020-06-010000-00-00NoNoCurrent
52389-166-56523890166562 TUBE in 1 CARTON (52389-166-56) > 28.35 g in 1 TUBE (52389-166-28) 2 tube2013-10-010000-00-00NoNoCurrent