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 24 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Marcs Everyday Care Dandruff Anti-Dandruff	PYRITHIONE ZINC	Mark Glassman, Inc.	69baf948-25fc-41d6-8980-23634634953b	2024-11-11	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	SCALP HYDRATE ANTI-DANDRUFF SHAMPOO	Conopco, Inc. d/b/a/ Unilever	e4159032-fd45-82a3-e053-2a95a90a7935	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	SMOOTH FRIZZ ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	e3d78025-4935-c04b-e053-2995a90a609f	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	VIBRANT COLOR ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	e3d7c24a-cc18-c455-e053-2a95a90a2184	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	FRESH DETOX 2 IN 1 ANTI-DANDRUFF SHAMPOO	Conopco, Inc. d/b/a/ Unilever	cba3fe82-63ba-01e2-e053-2a95a90a5b82	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	CURL MOISTURE ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	e3c9a4e1-27bf-01d9-e053-2a95a90ab68d	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	SCALP HYDRATE ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	e415096f-5ef0-7603-e053-2995a90a34f1	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	FULL AND STRONG ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	e3d6fa29-3337-ca82-e053-2995a90a1a67	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	DAMAGE REPAIR ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	cb7d1fc3-d696-70f5-e053-2a95a90a1fa6	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	FULL AND STRONG ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	cb6d0697-a60a-1e2d-e053-2995a90abd1d	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	VIBRANT COLOR WITH ROSE ESSENCE ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	ca011b03-a261-1908-e053-2995a90ad970	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	SMOOTH FRIZZ ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	cb7facb9-eac2-6ebb-e053-2995a90a5923	2024-11-07	Warnings	Exact identifier application number: M032
RE-fresh Scalp Care	ROSE WATER AND NOURISH ANTI-DANDRUFF SHAMPOO	Conopco, Inc. d/b/a/ Unilever	c572074b-11b0-6f8a-e053-2a95a90a4355	2024-11-07	Warnings	Exact identifier application number: M032
RE-fresh Scalp Care	ROSE WATER AND NOURISH ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	c572a2ca-aac5-6fe8-e053-2995a90aeadc	2024-11-07	Warnings	Exact identifier application number: M032
bhs beautiful hair and scalp	CURL MOISTURE ANTI-DANDRUFF CONDITIONER	Conopco, Inc. d/b/a/ Unilever	cb6be585-d638-9cd9-e053-2a95a90aa1e6	2024-11-07	Warnings	Exact identifier application number: M032
Dercos Salicylic Acid Anti-Dandruff Serum	SALICYLIC ACID	L'Oreal USA Products Inc	79a5f545-b3be-4bc3-9fc9-d2346ef17a1b	2024-11-07	Warnings	Exact identifier application number: M032
Equate Medicated Dandruff Anti-Dandruff	SELENIUM SULFIDE	Wal-Mart Stores, Inc.	3afbdc09-622d-4681-a6fb-8429a0a3df39	2024-11-07	Warnings	Exact identifier application number: M032
ELF Blemish Control Face Primer Clear	SALICYLIC ACID	e.l.f. Cosmetics, Inc	21bdbc81-d243-439b-ac90-31d9107222b4	2024-11-06	Warnings	Exact identifier application number: M032
ELF Clear Blemish Control Face Primer	SALICYLIC ACID	e.l.f. Cosmetics, Inc	94cfd075-41cc-402b-9d82-38bb6acda5b1	2024-11-06	Warnings	Exact identifier application number: M032
ELF ACNE Fighting Spot Gel with Aloe Clear	SALICYLIC ACID	e.l.f. Cosmetics, Inc	6ab34d5e-4439-4c64-ad0d-6c8641109c38	2024-11-06	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