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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52389-166		D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-01	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-21	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-42	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-43	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-56	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-57	D	Discontinued by firm	2026-10-05

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-166-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-166-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-166-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-166-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-166-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-166-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-166-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-166-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-166-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-166-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-166-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-166-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-166-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-166-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-166-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-166-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-166-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-166-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-166-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-166-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-166-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-166-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Coal tar	ACTIVE INGREDIENT	R533ESO2EC	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Coal tar	ACTIVE MOIETY	R533ESO2EC	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-166	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	13	Legacy NDC	20241106_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 2 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
apgwgzminoxidil5%	MINOXIDIL	Guangdong Jiaoyu Biotechnology Co., Ltd	596d0b43-5cb1-be25-e063-6394a90abbed	2026-08-19	Warnings	Exact identifier application number: M032
TEA TREE Oil DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	280391ce-ccd9-4b39-95a2-93e7fca84ccc	2026-08-18	Warnings	Exact identifier application number: M032
apgwgzminoxidil2%	MINOXIDIL	Guangdong Jiaoyu Biotechnology Co., Ltd	5957c990-e274-6278-e063-6394a90af2b7	2026-08-18	Warnings	Exact identifier application number: M032
EVERYDAY CLEAN DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	3983b688-28ae-462e-8686-6cf2f2c1cca4	2026-08-18	Warnings	Exact identifier application number: M032
Prosoria Psoriasis Treatment	SALICYLIC ACID	Nuvothera, Inc.	378311aa-95f7-4c69-bc00-e688468262bd	2026-08-18	Warnings	Exact identifier application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream	SALICYLIC ACID 3%	RoyceDerm LLC	496e178b-e29b-071e-e063-6394a90aa018	2026-08-13	Warnings	Exact identifier application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.	SALICYLIC ACID 3%	RoyceDerm LLC	4995ce33-e231-8f86-e063-6394a90af486	2026-08-13	Warnings	Exact identifier application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief	PYRITHIONE ZINC	Rida LLC	d1e4dee7-5962-4ec1-ab99-9d547077b2f2	2026-08-05	Warnings	Exact identifier application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief Treatment	SALICYLIC ACID	Rida LLC	6226ce12-432f-402e-bda7-a5ca96f0b838	2026-08-05	Warnings	Exact identifier application number: M032
JOHNSON FOAM	MINOXIDIL	JOHNSON BIOPHARMACEUTICAL INC.	1d44a75c-c940-680c-e063-6394a90a5839	2026-08-02	Warnings	Exact identifier application number: M032
EVERYDAY CLEAN DANDRUFF	PYRITHIONE ZINC	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	5a03d4bb-72e6-cc9f-e063-6394a90ae19f	2026-08-01	Warnings	Exact identifier application number: M032
TEA TREE Oil DANDRUFF	PYRITHIONE ZINC	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	5a0505a6-77ca-c56e-e063-6394a90aea6f	2026-08-01	Warnings	Exact identifier application number: M032
ITCHY SCALP RELIEF DANDRUFF	PYRITHIONE ZINC	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	5a0521cd-2b9e-e02c-e063-6394a90a5f02	2026-08-01	Warnings	Exact identifier application number: M032
SMOOTH AND SOFT DANDRUFF	PYRITHIONE ZINC	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	5a054179-b0d7-3a0f-e063-6294a90a6209	2026-08-01	Warnings	Exact identifier application number: M032
FOLKI COSMETIC Psoriasis Cream	SALICYLIC ACID 3% PSORIASIS CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	575786e0-21b8-ad9d-e063-6394a90ad0d4	2026-07-24	Warnings	Exact identifier application number: M032
RoyceDerm Psoriasis Scalp .spray.	SALICYLIC ACID 2%	RoyceDerm LLC	57425b1a-4cf3-b133-e063-6394a90a84f5	2026-07-23	Warnings	Exact identifier application number: M032
RoyceDerm Psoriasis Scalp .Shampoo.	SALICYLIC ACID 3%	RoyceDerm LLC	5743f813-57f7-f544-e063-6294a90ad3b8	2026-07-23	Warnings	Exact identifier application number: M032
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis Cream	SEBORRHEIC DERMATITIS PSORIASIS CREAM	BENLONG HALL LLC	36086f7f-8536-417f-a302-37f78288489e	2026-07-20	Warnings	Exact identifier application number: M032
5%MINOXIDIL TOPICAL FOAM	MINOXIDIL	Veloce Trading Co., Limited	56f87881-653f-17e6-e063-6294a90a6787	2026-07-19	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R533ESO2EC	COAL TAR	8007-45-2	COAL TAR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-166-01	52389016601	1 TUBE in 1 CARTON (52389-166-01) > 28.35 g in 1 TUBE (52389-166-28)	1 tube	2013-03-15	0000-00-00	No	No	Current
52389-166-43	52389016643	2 TUBE in 1 BOX (52389-166-43) > 21.25 g in 1 TUBE	2 tube	2020-06-01	0000-00-00	No	No	Current
52389-166-56	52389016656	2 TUBE in 1 CARTON (52389-166-56) > 28.35 g in 1 TUBE (52389-166-28)	2 tube	2013-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Psoriasin Gel	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2026-06-09	HUMAN OTC DRUG LABEL	15