Ciclopirox

Product NDC: 52565-032
Requested package NDC: 52565-032-12
11-digit product format: 525650032
Labeler code: 52565
Product ID: 52565-032_1ea9136f-7e4f-46a0-b740-5a130b190809
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciclopirox
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA209975
Marketing category: ANDA
Marketing start: 2018-04-05
Marketing end: 0000-00-00
Substance: CICLOPIROX
Active strength: 10 mg/.96mL
Pharmacologic classes: Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-032	52565-032-12	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209975-001	CICLOPIROX	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT		2018-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209975-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL		2018-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209975-001	CICLOPIROX	1%	SHAMPOO / TOPICAL	AT	2018-04-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209975-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209975-001	AT	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209975-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209975-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209975-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209975-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209975-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209975-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209975-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209975-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209975-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209975-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209975-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209975-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209975-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A209975-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209975-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209975-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209975-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209975-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209975-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209975-001	AT	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d24c6245-86b5-4444-bc75-c1ac73ab3016	Product name	1	20180612
c7015f08-288e-4cfa-93b5-f4959a4814ae	Product name	1	20150324
3f974526-143f-9d19-ee0c-98eeee0cdc3f	Product name	1	20140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-032-12	2023-01-30	C162847	48780-1	f386c649-f5a2-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CICLOPIROX SHAMPOO safely and effectively. See full prescribing information for CICLOPIROX SHAMPOO. CICLOPIROX Shampoo 1% for topical use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52565-032-12	Ciclopirox	1 in 1 CARTON	SHAMPOO	1		2
52565-032-12	Ciclopirox	120 mL in 1 BOTTLE, PLASTIC	SHAMPOO	120		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-032-12	ML - Milliliter	52565-032	3d1399db-7a9a-412e-a196-4e8b47bdc6f2	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-032	CICLOPIROX SHAMPOO [TELIGENT PHARMA, INC.]	2	Legacy NDC, 2 package rows	20190910_4db19b1a-6c1a-159f-7d88-61429bbbcb56.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CICLOPIROX	CICLOPIROX	Encube Ethicals, Inc.	cb456f2e-6645-4cc4-8e71-299c47ccb6b7	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209975 application number: ANDA209975

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19W019ZDRJ	CICLOPIROX	29342-05-0	CICLOPIROX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
250344	ciclopirox 1 % Medicated Shampoo	PSN	4db19b1a-6c1a-159f-7d88-61429bbbcb56	2
250344	ciclopirox 10 MG/ML Medicated Shampoo	SCD	4db19b1a-6c1a-159f-7d88-61429bbbcb56	2
250344	ciclopirox 1 % Medicated Shampoo	SY	4db19b1a-6c1a-159f-7d88-61429bbbcb56	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-032-12	52565003212	1 BOTTLE, PLASTIC in 1 CARTON (52565-032-12) > 120 mL in 1 BOTTLE, PLASTIC	2018-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox - Teligent Pharma, Inc.	Teligent Pharma, Inc.	2018-04-05	HUMAN PRESCRIPTION DRUG LABEL	2