Ciclopirox Olamine

Product NDC: 68258-3996
11-digit product format: 682583996
Labeler code: 68258
Product ID: 68258-3996_6b02cebe-eea9-464f-88eb-7c9db13b79fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciclopirox Olamine
Dosage form: CREAM
Route: TOPICAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA090273
Marketing category: ANDA
Marketing start: 2009-11-13
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-3996		I	Inactivated by FDA		2026-08-17
excluded package	package	68258-3996	68258-3996-3	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 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	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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`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	68258-3996-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-3996-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-3996-3	`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
A090273-001	CICLOPIROX	CICLOPIROX	0.77%	CREAM / TOPICAL	AB		2009-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090273-001	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	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090273-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2009-11-10	`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	A090273-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090273-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090273-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090273-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090273-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090273-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090273-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090273-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090273-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090273-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090273-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090273-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090273-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090273-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090273-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090273-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090273-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090273-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090273-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090273-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090273-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090273-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090273-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090273-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090273-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090273-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090273-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090273-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090273-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090273-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090273-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090273-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090273-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090273-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090273-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090273-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090273-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090273-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090273-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090273-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-3996-3	2019-11-27	C162847	48780-1	9855d018-de92-cd31-e053-dbdaa90ab51a	Ciclopirox Olamine Cream USP, 0.77%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-3996-3	Ciclopirox Olamine	30 g in 1 CARTON	CREAM	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CICLOPIROX OLAMINE	ACTIVE INGREDIENT	50MD4SB4AP	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
CICLOPIROX	ACTIVE MOIETY	19W019ZDRJ	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
MYRISTYL ALCOHOL	INACTIVE INGREDIENT	V42034O9PU	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-3996	CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.]	3	Legacy NDC, 1 package rows	20121004_9982d093-9f17-48de-8d06-b8256a20c764.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciclopirox Olamine	CICLOPIROX OLAMINE	Glenmark Pharmaceuticals Inc., USA	7385cf42-9f80-4542-8e0f-a0228aa9b43a	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090273 application number: ANDA090273
Ciclopirox Olamine	CICLOPIROX OLAMINE	Advanced Rx Pharmacy of Tennessee, LLC	f186e394-7390-4b8a-e053-2a95a90abed1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090273 application number: ANDA090273

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309289	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Cream	PSN	9982d093-9f17-48de-8d06-b8256a20c764	3
309289	ciclopirox 7.7 MG/ML Topical Cream	SCD	9982d093-9f17-48de-8d06-b8256a20c764	3
309289	ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical Cream	SY	9982d093-9f17-48de-8d06-b8256a20c764	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68258-3996-3	68258399603	30 g in 1 CARTON	30 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciclopirox Olamine Cream USP, 0.77%	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-03	HUMAN PRESCRIPTION DRUG LABEL	3