CICLOPIROX

Product NDC: 71335-2836
Requested package NDC: 71335-2836-1
11-digit product format: 713352836
Labeler code: 71335
Product ID: 71335-2836_aa26cf31-7dfe-4454-9d18-53ecd28dbc15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciclopirox
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA077687
Marketing category: ANDA
Marketing start: 2023-11-09
Substance: CICLOPIROX
Active strength: 80 mg/mL
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077687-001	CICLOPIROX	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077687-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	2007-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077687-001	CICLOPIROX	8%	SOLUTION / TOPICAL		2007-09-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077687-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077687-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077687-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077687-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077687-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077687-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077687-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077687-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077687-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077687-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077687-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077687-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077687-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077687-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077687-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077687-001	AT	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A077687-001	AT	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A077687-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077687-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077687-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077687-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077687-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077687-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077687-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077687-001	AT	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077687-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CICLOPIROX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CICLOPIROX	80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19W019ZDRJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309291	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1548af93-0dc1-4606-865f-6201b2bb7de1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2836-1	CICLOPIROX	1 in 1 CARTON	SOLUTION	1		100
71335-2836-1	CICLOPIROX	6.6 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	6.6		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2836-1	ML - Milliliter	71335-2836	677b094b-5ce0-4538-934d-110c1f8a2daa	1	2025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	f3e0ea78-42c0-4430-b299-fffee9e09c16	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077687 application number: ANDA077687
CICLOPIROX	CICLOPIROX	Preferred Pharmaceuticals Inc.	eb7b7163-2ee7-447a-b585-7a240070f84b	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077687 application number: ANDA077687
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	1548af93-0dc1-4606-865f-6201b2bb7de1	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077687 application number: ANDA077687 ndc (package): 71335-2836-1 ndc (product): 71335-2836 ndc11 (package): 71335283601
CICLOPIROX	CICLOPIROX	Encube Ethicals, Inc.	79084b47-7481-4926-9837-e08f633b1ddf	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077687 application number: ANDA077687

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
309291	ciclopirox 8 % Topical Solution	PSN	1548af93-0dc1-4606-865f-6201b2bb7de1	100
309291	ciclopirox 80 MG/ML Topical Solution	SCD	1548af93-0dc1-4606-865f-6201b2bb7de1	100
309291	ciclopirox 8 % (nail lacquer) Topical Solution	SY	1548af93-0dc1-4606-865f-6201b2bb7de1	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2836-1	71335283601	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2836-1) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR	2025-10-22	No	No	Current