Ciclopirox

Product NDC: 0168-0407
11-digit product format: 001680407
Labeler code: 0168
Product ID: 0168-0407_0c2acee6-0de3-4a80-9483-c45c8506e504
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciclopirox
Dosage form: GEL
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application: ANDA077896
Marketing category: ANDA
Marketing start: 2008-06-10
Marketing end: 0000-00-00
Substance: CICLOPIROX
Active strength: 8 mg/g
Pharmacologic classes: Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0168-0407		I	Inactivated by FDA	2026-08-17
excluded package	package	0168-0407	0168-0407-30	I	Inactivated by FDA	2026-08-17
excluded package	package	0168-0407	0168-0407-46	I	Inactivated by FDA	2026-08-17
excluded package	package	0168-0407	0168-0407-99	I	Inactivated by FDA	2026-08-17

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 · 88 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	0168-0407-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0407-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0407-46	`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	0168-0407-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0407-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0407-46	`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	0168-0407-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0407-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0407-46	`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	0168-0407-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0407-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0407-46	`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	0168-0407-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0407-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0407-46	`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	0168-0407-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0407-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0407-46	`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	0168-0407-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0407-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0407-46	`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	0168-0407-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0407-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0407-46	`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	0168-0407-99	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0407-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0407-46	`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	0168-0407-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0407-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0407-46	`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	0168-0407-99	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0407-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0407-46	`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	0168-0407-99	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0407-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0407-46	`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	0168-0407-99	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0168-0407-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0168-0407-46	`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	0168-0407-99	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0168-0407-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0168-0407-46	`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	0168-0407-99	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0168-0407-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0168-0407-46	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077896-001	CICLOPIROX	CICLOPIROX	0.77%	GEL / TOPICAL	AB		2008-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077896-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077896-001	CICLOPIROX	0.77%	GEL / TOPICAL	AB	2008-06-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077896-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077896-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077896-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077896-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077896-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077896-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077896-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077896-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077896-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077896-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077896-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077896-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077896-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077896-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077896-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077896-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077896-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077896-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077896-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077896-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077896-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077896-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077896-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077896-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077896-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077896-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077896-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077896-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077896-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077896-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077896-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077896-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077896-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077896-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077896-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077896-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077896-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077896-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077896-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077896-001	AB	1	`e64feba35796…`

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
0168-0407-30	2020-01-31	C162847	48780-1	9d75b9d0-f6a6-f424-e053-dadaa90a57ce	CICLOPIROX GEL 0.77%
0168-0407-46	2020-01-31	C162847	48780-1	9d75b9d0-f6a6-f424-e053-dadaa90a57ce	CICLOPIROX GEL 0.77%
0168-0407-99	2020-01-31	C162847	48780-1	9d75b9d0-f6a6-f424-e053-dadaa90a57ce	CICLOPIROX GEL 0.77%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0168-0407-30	Ciclopirox	30 g in 1 TUBE	GEL	30	6
0168-0407-46	Ciclopirox	45 g in 1 TUBE	GEL	45	6
0168-0407-99	Ciclopirox	100 g in 1 TUBE	GEL	100	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0407-30	GM - Gram	0168-0407	4fb7c745-7889-4841-a247-8fd3448efda4	1	2012-07-24
0168-0407-46	GM - Gram	0168-0407	b574a866-ebfb-4e34-85ff-3beceee1577c	1	2013-02-13
0168-0407-99	GM - Gram	0168-0407	a3b16523-549b-4237-9d19-ad9f8899027e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CICLOPIROX	ACTIVE INGREDIENT	19W019ZDRJ	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
CICLOPIROX	ACTIVE MOIETY	19W019ZDRJ	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
PEG/PPG-18/18 DIMETHICONE	INACTIVE INGREDIENT	9H0AO7T794	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0407	CICLOPIROX GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	6	Legacy NDC, 3 package rows	20150729_88324009-d5cc-4982-be3e-058e0436f608.zip

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
313941	ciclopirox 0.77 % Topical Gel	PSN	88324009-d5cc-4982-be3e-058e0436f608	6
313941	ciclopirox 0.0077 MG/MG Topical Gel	SCD	88324009-d5cc-4982-be3e-058e0436f608	6
313941	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Gel	SY	88324009-d5cc-4982-be3e-058e0436f608	6
313941	ciclopirox 0.77 % Topical Gel	SY	88324009-d5cc-4982-be3e-058e0436f608	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0168-0407-30	00168040730	30 g in 1 TUBE	30 g	Historical
0168-0407-46	00168040746	45 g in 1 TUBE	45 g	Historical
0168-0407-99	00168040799	100 g in 1 TUBE	100 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CICLOPIROX GEL 0.77%	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2013-10-15	HUMAN PRESCRIPTION DRUG LABEL	6