CICLOPIROX OLAMINE

Product NDC: 49999-646
11-digit product format: 499990646
Labeler code: 49999
Product ID: 49999-646_fce94d1c-69de-4bfa-854e-d08a2de7327e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CICLOPIROX OLAMINE
Dosage form: CREAM
Route: TOPICAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA077364
Marketing category: ANDA
Marketing start: 2010-11-03
Marketing end: 0000-00-00
Substance: CICLOPIROX OLAMINE
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49999-646		D	Discontinued by firm		2026-08-17
excluded package	package	49999-646	49999-646-15	D	Discontinued by firm		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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-646-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-646-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-646-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-646-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-646-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-646-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-646-15	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-646-15	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-646-15	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-646-15	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-646-15	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-646-15	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49999-646-15	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49999-646-15	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49999-646-15	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49999-646-15	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49999-646-15	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49999-646-15	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49999-646-15	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49999-646-15	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49999-646-15	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49999-646-15	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A077364-001	CICLOPIROX	CICLOPIROX	0.77%	CREAM / TOPICAL	AB		2006-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077364-001	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	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`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	A077364-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49999-646-15	2025-01-16	C162847	48780-1	9d75b9d0-4ff9-f424-e053-dadaa90a57ce	Ciclopirox Olamine 15g Cream
49999-646-15	2020-01-31	C162847	48780-1	9d75b9d0-4ff9-f424-e053-dadaa90a57ce	Ciclopirox Olamine 15g Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-646-15	GM - Gram	49999-646	e2c5ce5d-aa08-4dad-8bed-ca6f643e93f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CICLOPIROX OLAMINE	ACTIVE INGREDIENT	50MD4SB4AP	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
CICLOPIROX	ACTIVE MOIETY	19W019ZDRJ	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006
WATER	INACTIVE INGREDIENT	059QF0KO0R	CICLOPIROX OLAMINE CREAM [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2006

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	6d02fb24-9736-4fe3-b909-1b2172aa2773	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	74fda3b8-d1f0-4ade-a92a-286f3874f292	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	aa326ade-ff55-4355-b6c7-205d6d88d0a3	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Padagis Israel Pharmaceuticals Ltd	1a74ed86-997a-4b86-b54a-b2b2c94e8abb	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	81e31568-6d87-4d0b-ba52-d2794a7cb023	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50MD4SB4AP	CICLOPIROX OLAMINE	41621-49-2	CICLOPIROX OLAMINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox Olamine 15g Cream	Lake Erie Medical DBA Quality Care Products LLC \| L.Perrigo Company	2010-11-03	HUMAN PRESCRIPTION DRUG LABEL	2006