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	2026-10-12
excluded package	package	52389-166	52389-166-01	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-21	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-42	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-43	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-56	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-57	D	Discontinued by firm	2026-10-12

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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHARMBANNER Anti-Fungal Shampoo.	ANTI-FUNGAL SHAMPOO	Shenzhen Xinxin Yunhai Technology Co., Ltd.	383926b7-997b-af1e-e063-6394a90a506d	2025-06-23	Warnings	Exact identifier application number: M032
Brickell Mens Products Relieving Anti-Dandruff	SALICYLIC ACID	BRICKELL BRANDS LLC	7ba3b13b-cb78-4df8-8719-c88e556643b4	2025-06-16	Warnings	Exact identifier application number: M032
VENROCK	PIROCTONE OLAMINE AND SALICYLIC ACID	Guangzhou Oupeng Cosmetics Co., Ltd.	372feca7-f6f1-cd38-e063-6294a90a3bfe	2025-06-12	Warnings	Exact identifier application number: M032
Neutrogena T/Sal Therapeutic	SALICYLIC ACID	Kenvue Brands LLC	54707f0f-6025-4dc3-8be8-7a38bb1363b8	2025-06-05	Warnings	Exact identifier application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to Foam	SALICYLIC ACID	PRODUCTOS CAPILARES L'OREAL SA	aae04d08-9d0c-43bd-89c2-741884de3bea	2025-06-04	Warnings	Exact identifier application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to Foam	SALICYLIC ACID	L'Oreal USA Products Inc	bcffd505-82bd-45ce-9ad0-64a9e63f62b5	2025-06-04	Warnings	Exact identifier application number: M032
UCHOIZE S2 Balance Anti-Dandruff	UCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOO	Dreamwise International Corp	36a5efa8-0617-868d-e063-6394a90a1705	2025-06-03	Warnings	Exact identifier application number: M032
DermaD ATOPIC DERMATITIS Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	d872a4ee-554e-4bca-acb1-3bbf57dc690b	2025-05-29	Warnings	Exact identifier application number: M032
DermaD JOCK ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	c8c0449c-11f9-4434-a91c-b690d6780820	2025-05-29	Warnings	Exact identifier application number: M032
DermaD Psoriasis Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	e52c647b-8cdc-4023-af22-fbfb84ea0ada	2025-05-27	Warnings	Exact identifier application number: M032
DermaER Psoriasis Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	f62e6c5e-6e80-4b75-a0b1-c893224d9ce4	2025-05-27	Warnings	Exact identifier application number: M032
DermaZinc	PYRITHIONE ZINC	WynnPharm Inc	e71e87ba-2a62-44f3-e053-2995a90a8b11	2025-05-25	Warnings	Exact identifier application number: M032
Tagrid ANTI FUNGAL	ZINC PYRITHIONE,SALICYLIC ACID	TAGRID LLC	3376b104-1f07-fab3-e063-6394a90a0ca4	2025-05-22	Warnings	Exact identifier application number: M032
Coal Tar	COAL TAR	Nopsor USA Distribution Co., Inc.	407bd007-bec6-2864-e054-00144ff88e88	2025-05-05	Warnings	Exact identifier application number: M032
AntiDandruffShampoo	365 ANTI DANDRUFF SHAMPOO	Whole Foods Market, Inc.	b9bc6bbb-31c5-427e-e053-2995a90a5f17	2025-04-29	Warnings	Exact identifier application number: M032
AntiDandruffShampooConditioner	365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1	Whole Foods Market, Inc.	c3f5b5fb-acb0-a904-e053-2995a90a5623	2025-04-29	Warnings	Exact identifier application number: M032
UTTSE Anti Fungal Shampoo.	ANTI FUNGAL SHAMPOO	Shenzhen Xinxin Yunhai Technology Co., Ltd.	33bebbe9-e0ab-2f7d-e063-6294a90add4e	2025-04-27	Warnings	Exact identifier application number: M032
Psalmonica Hair Growth Serum	MINOXIDIL	Guangzhou Haishi Biological Technology Co., Ltd.	3380fe6d-e057-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint	PYRITHIONE ZINC SHAMPOO	China Ningbo Shangge Cosmetics Technology Corp.	3344c97b-8767-3f87-e063-6394a90a4f5d	2025-04-21	Warnings	Exact identifier application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter	PYRITHIONE ZINC SHAMPOO	China Ningbo Shangge Cosmetics Technology Corp.	3346e2c5-af28-74ad-e063-6394a90abbab	2025-04-21	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