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 22 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Dandruff 2 in 1	PYRITHIONE ZINC	CHAIN DRUG MARKETING ASSOCIATION, INC.	2c6289a3-2f09-c094-e063-6394a90a81f9	2025-01-23	Warnings	Exact identifier application number: M032
Tuymec Anti-Fungal Shampoo.	ANTI-FUNGAL SHAMPOO	Guangzhou Zanming Trading Co., Ltd.	2c62d04e-dcb6-a33e-e063-6394a90a2e8e	2025-01-23	Warnings	Exact identifier application number: M032
QC Anti Dandruff T Plus	COAL TAR	Chain Drug Marketing Association, Inc.	2bea5414-c7bc-d010-e063-6294a90aa138	2025-01-17	Warnings	Exact identifier application number: M032
Meijer Medicated Selenium Sulfide Anti-Dandruff	SELENIUM SULFIDE	Meijer Distribution, Inc	41b563c6-5df6-4ead-bddf-a69a07970ea0	2025-01-14	Warnings	Exact identifier application number: M032
D-COL Personal Hygiene Convenience kit	PYRITHIONE ZINC AND CHLOROXYLENOL	D-COL Inc	273fcc6f-9c54-42b0-aa0c-9051457b1341	2025-01-14	Warnings	Exact identifier application number: M032
Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	f8767db7-e208-4ccc-85f7-789e281c7f26	2025-01-10	Warnings	Exact identifier application number: M032
Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	c759b347-bdfb-4ff5-a464-b40fa2efb843	2025-01-10	Warnings	Exact identifier application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	d561e8d2-2761-422b-8f05-ac76d3a043eb	2025-01-10	Warnings	Exact identifier application number: M032
Royal Oils by Head and Shoulders Sulfate Free Scalp Care	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	d73ab807-027f-7581-e053-2995a90ada83	2025-01-08	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Color Protect Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86ac3037-9ff2-25ea-e053-2a91aa0a43e3	2025-01-08	Warnings	Exact identifier application number: M032
Oribe Serene Scalp Anti Dandruff	ORIBE SERENE SCALP ANTI DANDRUFF	Oribe Hair Care LLC	e5702ac7-e680-ab4b-e053-2995a90ad442	2025-01-01	Warnings	Exact identifier application number: M032
Oribe Serene Scalp Anti Dandruff	ORIBE SERENE SCALP ANTI DANDRUFF	Oribe Hair Care LLC	abaf1c64-1c4d-481a-9872-b64fcf82cc63	2025-01-01	Warnings	Exact identifier application number: M032
Dr. Groot Anti-dandruff Scalp Care	SALICYLIC ACID	TAI GUK PHARM. CO., LTD	e8bdad4d-d499-70a9-e053-2a95a90a5cd9	2025-01-01	Warnings	Exact identifier application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1	SALICYLIC ACID	TAI GUK PHARM. CO., LTD	e8bf3852-e963-7a48-e053-2995a90a5aa1	2025-01-01	Warnings	Exact identifier application number: M032
American Crew	PYRITHIONE ZINC	Revlon Consumer Products Corp	9566b567-90be-4803-b940-e6a91750778f	2024-12-30	Warnings	Exact identifier application number: M032
Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff Treatment	SALICYLIC ACID	L'Oreal USA Products Inc.	d72688ed-d153-4eed-988f-5386eb68559d	2024-12-30	Warnings	Exact identifier application number: M032
Dermaharmony Seborrheic Dermatitis	PYRITHIONE ZINC	D3 Development, Inc.	8d81521d-9e6f-1acf-e053-2995a90a9242	2024-12-20	Warnings	Exact identifier application number: M032
Dermaharmony Sulfur and Salicylic Acid	SALICYLIC ACID, SULFUR	D3 Development, Inc.	a1c61da2-7e7a-430a-e053-2995a90ad594	2024-12-20	Warnings	Exact identifier application number: M032
Dermaharmony Bar Peppermint	SALICYLIC ACID, SULFUR	D3 Development, Inc.	af7060a9-986c-500e-e053-2a95a90a6438	2024-12-20	Warnings	Exact identifier application number: M032
Dermaharmony Bar Peppermint	PYRITHIONE ZINC	D3 Development, Inc.	a19b74b0-88c6-6897-e053-2a95a90a7309	2024-12-20	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