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 14 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders Itchy Scalp 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	157c3f81-f37e-4dab-b724-50fe0d9e1a26	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Conditioner Smooth and Silky	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	41709710-539c-3119-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Care Hair and Scalp Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	42620236-17ef-5c70-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Hair and Scalp Conditioner Green Apple	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4534c7a7-bc4b-3851-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Old Spice Pure Sport	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7bbfc667-bf9b-08c2-e053-2a91aa0a8009	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Royal Oils Daily Moisture Scalp	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7b1f81e1-1fee-5be2-e053-2a91aa0aa063	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Royal Oils Instant Soothe Scalp	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Coconut Daily Hair and Scalp Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7cc10c1b-fe0b-7d4c-e053-2a91aa0a2377	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Men Advanced Series Swagger Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3cdf44-ae1d-fed5-e053-2a91aa0a3021	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Detox and Hydrate	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	8659218e-cb8d-bb44-e053-2a91aa0ae37b	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Soothe and Strengthen	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86972263-dcef-358f-e053-2991aa0a734f	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Color Protect	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	8697a03b-7050-3a49-e053-2a91aa0a7271	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Detox and Hydrate Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86ab72bc-4e9d-0075-e053-2a91aa0a1135	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Soothe and Strengthen Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86abfdc2-d55b-4adb-e053-2991aa0a54b1	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Advanced Series Bourbon 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	98480eaa-6798-4efe-e053-2a95a90a869f	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Advanced Series Sandalwood 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	9858f681-1aca-e481-e053-2a95a90a869d	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Apple Cider Vinegar 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	b698b310-a794-e7f3-e053-2a95a90a47c4	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Dandruff Defense Dry Scalp Rescue	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	c7bc3942-6943-2ea5-e053-2a95a90a42a9	2025-12-18	Warnings	Exact identifier application number: M032
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	c95e82e4-74fb-9dbf-e053-2a95a90a93e5	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Moisturizing Avocado Oil	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	d08969cb-24ca-c49c-e053-2a95a90a71d1	2025-12-18	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