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 10 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dry Scalp	PYRITHIONE ZINC	Valu Merchandisers Company	6349fd91-675b-4489-8b57-e584f718ca3f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	Valu Merchandisers Company	e9fc676c-0313-430f-a422-6dba51241bd5	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Valu Merchandisers Company	d5dd333d-fea5-4e03-bd9f-cbc28ea48a80	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	United Natural Foods, Inc. dba UNFI	66f301bf-8e2e-43ce-b6b8-0983fe795f01	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M032
Tuymec Anti-Dandruff Shampoo.	ANTI-DANDRUFF SHAMPOO.	Guangzhou Jingliang Cosmetics Co., Ltd.	4ae93408-5c8f-c0a5-e063-6394a90a9e0d	2026-02-15	Warnings	Exact identifier application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream	SALICYLIC ACID 3%	RoyceDerm LLC	4ac42528-9210-6936-e063-6294a90a4168	2026-02-14	Warnings	Exact identifier application number: M032
OLIVITA 5% Minoxidil	5% MINOXIDIL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	4acbdf3d-976a-2cba-e063-6294a90a35e6	2026-02-14	Warnings	Exact identifier application number: M032
VENANOCI Minoxidil	MINOXIDIL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	4acc38aa-13da-981b-e063-6294a90aede5	2026-02-14	Warnings	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	Topco Associates LLC	fc568c8f-0d59-4b26-8f72-ea70e4316687	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Topco Associates LLC	a0f2c58b-bb17-42a3-bd90-be771f60ef20	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Topco Associates LLC	706b856c-ce89-4860-bc5d-9803deb469e7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	Topco Associates LLC	3300bfd5-ae84-4bc8-a4cd-05472b498fb7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean	PYRITHIONE ZINC	Topco Associates LLC	c0abb41f-9df0-4493-8452-592ec30c7924	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Topco Associates LLC	7da1e057-a69e-4b89-a309-919d88da3b93	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Pyrithione zinc	PYRITHIONE ZINC	Topco Associates LLC	2c1420a8-404f-4fd7-8f07-cd441b390ac2	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	WinCo Foods, LLC	2581c531-c068-4dae-b569-3b1f86dad066	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp	PYRITHIONE ZINC	WinCo Foods, LLC	4fca1200-dc6c-4e6e-b09c-2ec8ac0fa411	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean 2 in 1	PYRITHIONE ZINC	WinCo Foods, LLC	8bd391ae-0eeb-4e7d-b1e5-20e4adb1da17	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean 2 in 1	PYRITHIONE ZINC	Your Military Exchanges	a62b282f-e928-42bb-b595-d5f2066aac63	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M032
natouch	PYRITHIONE ZINC	Natouch LLC	0f330e2d-25d7-5e0e-e063-6394a90acda9	2026-02-10	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