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 9 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dandruff	PYRITHIONE ZINC 1%	Meijer, Inc.	28525947-97f6-4b3f-b8bd-596ffcf61188	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp	PYRITHIONS ZINC	Meijer, Inc.	57a944af-397f-41d9-bfe0-7cac0dd26cb1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean	PYRITHIONE ZINC	Meijer, Inc.	9ca4dd70-3dca-4d5a-a13d-51a5dbf92af0	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M032
Head and Shoulders Hydrating Coconut Kit	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4b33d7cd-93ae-6ec9-e063-6294a90afc63	2026-02-19	Warnings	Exact identifier application number: M032
Dandruff	SELENIUM SULFIDE	Meijer, Inc.	c0e4f8cb-74fc-4c0d-9721-f87aa2aa1992	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M032
Selsun Blue Naturals Itchy, Dry Scalp	SALICYLIC ACID	Chattem, Inc.	ed031a0f-7467-4b2c-a6b6-95306f6ee828	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Hydrating Coconut 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4b1a4f24-ff9b-9677-e063-6294a90a9c22	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Coconut 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7cc1c6c8-27cd-6d9e-e053-2991aa0a99df	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Tea Tree Oil 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	96b37f23-230f-0652-e053-2a95a90a1f64	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp Care	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	38921198-56d3-ab01-e063-6394a90a89b9	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Smooth and Silky 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	2026-02-18	Warnings	Exact identifier application number: M032
Head and Shoulders Hydrating Coconut	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4b20caa0-9ec6-3bfc-e063-6294a90ac68e	2026-02-18	Warnings	Exact identifier application number: M032
Selsun Blue 2-in-1	SELENIUM SULFIDE	Chattem, Inc.	f97e458c-cce3-498f-81fc-1b96a4e8f50a	2026-02-18	Warnings	Exact identifier application number: M032
Selsun Blue Itchy Dry Scalp	PYRITHIONE ZINC	Chattem, Inc.	c491014d-f8c7-46bb-b065-eaf5ea842860	2026-02-18	Warnings	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	United Natural Foods, Inc. dba UNFI	77b2e0da-a6d7-42b5-92af-4e7979817b78	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	United Natural Foods, Inc. dba UNFI	064ff929-d965-4b1a-98a9-f2779f346d7f	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	United Natural Foods, Inc. dba UNFI	d7c4507e-7f74-4bcd-9b0e-0b097193a1a8	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	United Natural Foods, Inc. dba UNFI	ecc20b71-eb6b-43ed-86bc-32d61641ee3a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	TKC Holdings, Inc.	c3bc9a89-b1f3-4b7a-bebb-00c341956d60	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	Valu Merchandisers Company	bb0a74e0-2312-4444-b7e1-19a9a3a7007e	2026-02-16	Warnings, Adverse reactions	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