Zithranol

Product NDC: 42783-111
11-digit product format: 427830111
Labeler code: 42783
Product ID: 42783-111_29705f8e-766e-4ef9-9ca7-3e9a9dee9daa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anthralin
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Elorac Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2012-03-05
Marketing end: 0000-00-00
Substance: ANTHRALIN
Active strength: 1 g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42783-111		I	Inactivated by FDA	2026-10-05
excluded package	package	42783-111	42783-111-07	I	Inactivated by FDA	2026-10-05
excluded package	package	42783-111	42783-111-85	I	Inactivated by FDA	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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42783-111-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42783-111-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42783-111-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42783-111-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42783-111-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42783-111-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42783-111-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42783-111-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42783-111-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42783-111-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42783-111-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42783-111-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42783-111-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42783-111-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42783-111-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42783-111-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42783-111-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42783-111-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42783-111-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42783-111-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42783-111-85	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42783-111-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42783-111-85	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42783-111-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42783-111-85	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42783-111-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42783-111-85	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42783-111-07	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42783-111-85	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42783-111-07	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42783-111-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42783-111-85	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42783-111-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42783-111-85	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42783-111-07	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42783-111-85	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42783-111-07	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42783-111-85	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42783-111-07	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42783-111-85	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42783-111-07	2020-01-31	C162847	48780-1	9d75b9cf-e19e-f424-e053-dadaa90a57ce	253fdee7-5060-4b49-ad26-257eb54cccfa
42783-111-85	2020-01-31	C162847	48780-1	9d75b9cf-e19e-f424-e053-dadaa90a57ce	253fdee7-5060-4b49-ad26-257eb54cccfa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42783-111-07	Zithranol	1 in 1 CARTON	SHAMPOO	1	7
42783-111-07	Zithranol	24 in 1 CASE	SHAMPOO	24	7
42783-111-85	Zithranol	12 in 1 CASE	SHAMPOO	12	7
42783-111-85	Zithranol	1 in 1 CARTON	SHAMPOO	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42783-111-85	GM - Gram	42783-111	f895bba1-7c77-49cf-beab-fee8c0d9f12e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Anthralin	ACTIVE INGREDIENT	U8CJK0JH5M	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
Anthralin	ACTIVE MOIETY	U8CJK0JH5M	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
GLYCERETH-2 COCOATE	INACTIVE INGREDIENT	JWM00VS7HC	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
GLYCERYL LAURATE	INACTIVE INGREDIENT	Y98611C087	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
GLYCERYL MYRISTATE	INACTIVE INGREDIENT	6992Y81827	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42783-111	ZITHRANOL (ANTHRALIN) SHAMPOO [ELORAC INC.]	7	Legacy NDC, 4 package rows	20141018_253fdee7-5060-4b49-ad26-257eb54cccfa.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U8CJK0JH5M	ANTHRALIN	1143-38-0	ANTHRALIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245899	anthralin 1 % Medicated Shampoo	PSN	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245904	ZITHRANOL 1 % Medicated Shampoo	PSN	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245904	anthralin 10 MG/ML Medicated Shampoo [Zithranol]	SBD	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245899	anthralin 10 MG/ML Medicated Shampoo	SCD	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245899	anthralin 1 % Medicated Shampoo	SY	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245904	Zithranol 1 % Medicated Shampoo	SY	253fdee7-5060-4b49-ad26-257eb54cccfa	7
1245904	Zithranol 10 MG/ML Medicated Shampoo	SY	253fdee7-5060-4b49-ad26-257eb54cccfa	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42783-111-07	42783011107	1 in 1 CARTON	Historical
42783-111-85	42783011185	12 in 1 CASE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zithranol - Elorac Inc. \| Elorac, Inc.	Elorac Inc. \| Elorac, Inc.	2014-10-17	HUMAN PRESCRIPTION DRUG LABEL	7