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 27 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. Groot Anti-dandruff Scalp Care	SALICYLIC ACID	TAI GUK PHARM. CO., LTD	1e572a86-9115-4597-e063-6394a90a484e	2024-05-31	Warnings	Exact identifier application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1	SALICYLIC ACID	TAI GUK PHARM. CO., LTD	1e572a97-1a38-8360-e063-6394a90a47a3	2024-05-31	Warnings	Exact identifier application number: M032
Dr. Groot Anti-dandruff Scalp Care	SALICYLIC ACID	LG H&H CO., LTD.	1e584724-7059-38ab-e063-6394a90aceb7	2024-05-31	Warnings	Exact identifier application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1	SALICYLIC ACID	LG H&H CO., LTD.	1e584724-705a-38ab-e063-6394a90aceb7	2024-05-31	Warnings	Exact identifier application number: M032
Thera-Gel	COAL TAR	Major Pharmaceuticals	1c18fde9-d39b-4339-8f62-3f352d450291	2024-05-28	Warnings	Exact identifier application number: M032
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SALICYLIC ACID	TARGET CORPORATION	482332f8-0db4-4ec7-81e9-c4efbba16a26	2024-05-20	Warnings	Exact identifier application number: M032
True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Garcoa, Inc.	20116e1e-56f1-4018-99ef-758de7fc2464	2024-05-10	Warnings	Exact identifier application number: M032
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	TARGET CORPORATION	e315b2d8-304d-4807-9594-9286e9b642ef	2024-05-10	Warnings	Exact identifier application number: M032
amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	AMAZON.COM SERVICES LLC	0464b4ff-1be1-4d84-b7fd-b771ebc1e16c	2024-05-09	Warnings	Exact identifier application number: M032
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis	SELENIUM SULFIDE	Walgreen Company	cc83427d-49e6-4a20-9d03-9ec8ce27e487	2024-05-09	Warnings	Exact identifier application number: M032
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	Meijer Distribution, Inc	c8dee061-3362-400f-aa59-93ec0b8125ba	2024-05-01	Warnings	Exact identifier application number: M032
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	Walgreen Company	70c7b400-a295-4b99-8673-e6a38343d76f	2024-05-01	Warnings	Exact identifier application number: M032
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	TARGET CORPORATION	a516282f-ed6b-4e94-b269-ea34f700dd69	2024-04-25	Warnings	Exact identifier application number: M032
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SALICYLIC ACID	Walgreen Company	339d390e-0b09-4c42-af1f-9465daa9f7c9	2024-04-22	Warnings	Exact identifier application number: M032
Walgreens Everyday Clean Dandruff Anti-Dandruff	PYRITHIONE ZINC	Walgreen Company	930d92a9-d0bc-42e1-873e-5c27e93a39b5	2024-04-22	Warnings	Exact identifier application number: M032
Rugby Anti-Dandruff	SELENIUM SULFIDE	Rugby Laboratories	f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2	2024-03-14	Warnings	Exact identifier application number: M032
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff	SELENIUM SULFIDE	Cardinal Health, 110 dba LEADER	3f64a2ef-a415-49b0-bf14-eb4da66d511f	2024-03-13	Warnings	Exact identifier application number: M032
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis	SALICYLIC ACID	Cardinal Health, 110 dba LEADER	509434a9-50c4-4337-8e5b-17bdc667d23b	2024-03-13	Warnings	Exact identifier application number: M032
meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Meijer Distribution, Inc	f7cce683-6e1f-4214-a38b-37eb046b7f4d	2024-03-05	Warnings	Exact identifier application number: M032
Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasis	SALICYLIC ACID, SULFUR	Rugby Laboratories	aec81d61-1d28-490f-9654-f66bd4a30ffa	2024-03-01	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