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 11 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyday Clean Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	8fb44204-b763-4aa5-a6db-94d1b4d98b65	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	c1d8c237-1ca8-4fdb-ba94-787d3a9e6111	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	592ec7c5-44b8-405b-88a2-f02aa6c620f0	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	Retail Business Services, LLC	37357176-913d-4dd7-a565-ad21d4ad60a8	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	c8c82495-f09a-4ec1-9036-e464845e02f9	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	ec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Retail Business Services, LLC	841429c3-e15c-41cc-9ca8-6b5a21a21587	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Publix Super Markets, Inc.	56c2b8c2-69ea-4343-ae69-43f5966261c2	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Publix Super Markets, Inc.	8a204a2c-6dcb-4fc4-b265-9b95da204236	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	Harris Teeter	8594a944-a67e-4dbe-8d31-7099410ff484	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	Amazon.Com Services LLC	e30896df-e4b2-4b1f-a226-a26055a4a121	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M032
Oribe Serene Scalp Anti Dandruff	ORIBE SERENE SCALP ANTI DANDRUFF	Oribe Hair Care LLC	34c4abb5-6f96-4866-a37f-4f9be6c43f2b	2026-01-30	Warnings	Exact identifier application number: M032
NATUREPLEX PSORIASIS	SALICYLIC ACID	Natureplex, LLC	1efa3e8d-f80b-44f4-a233-187e3329dd8f	2026-01-29	Warnings	Exact identifier application number: M032
Head and Shoulders Charcoal Daily	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	69abc8fa-eee5-d36f-e053-2991aa0a940b	2026-01-28	Warnings	Exact identifier application number: M032
WeCare Anti-Dandruff	ANTIDANDRUFF SHAMPOO	Dynarex Corporation	7fad58a3-5537-f87a-e053-2991aa0a7cdb	2026-01-28	Warnings	Exact identifier application number: M032
TriDerma Psoriasis Control Face and Body Cream	SALICYLIC ACID	Genuine Virgin Aloe Corporation	66eeaf72-1fb4-4df0-9198-41f1143c67b3	2026-01-27	Warnings	Exact identifier application number: M032
TRIDERMA Psoriasis Control	SALICYLIC ACID	Genuine Virgin Aloe Corporation	16ba7145-0e8c-48b8-b557-43ac1be317ac	2026-01-27	Warnings	Exact identifier application number: M032
DHS tar gel	COAL TAR	Person and Covey	e17bd664-748b-417c-a247-9acc7bc7eec3	2026-01-23	Warnings	Exact identifier application number: M032
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SALICYLIC ACID	Garcoa, Inc.	620617e3-0ee1-469a-ad2b-0dda957627cc	2026-01-21	Warnings	Exact identifier application number: M032
Aloe Coal 02 Conditioner	PYRITHIONE ZINC	T. SPRUILL, LLC	e8e1fbe8-7de3-4a8e-bace-b7b2e4db1828	2026-01-19	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