Home NDC 0574-2061 CICLOPIROX
Product NDC 0574-2061
11-digit product format 005742061
Labeler code 0574
Product ID 0574-2061_04609ea1-41be-4aa6-ad71-7424db6ae548
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CICLOPIROX
Dosage form GEL
Route TOPICAL
Labeler Padagis US LLC
Application ANDA078266
Marketing category ANDA
Marketing start 2009-01-07
Substance CICLOPIROX
Active strength 7.7 mg/g
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 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 A078266-001 CICLOPIROX CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078266-001 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078266-001 CICLOPIROX 0.77% GEL / TOPICAL AB 2009-01-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CICLOPIROX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CICLOPIROX 7.7 mg/g
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 313941 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CICLOPIROX ACTIVE INGREDIENT 19W019ZDRJ CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 CICLOPIROX ACTIVE MOIETY 19W019ZDRJ CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 PEG/PPG-18/18 DIMETHICONE INACTIVE INGREDIENT 9H0AO7T794 CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CICLOPIROX GEL [PADDOCK LABORATORIES, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-2061 CICLOPIROX GEL [PADAGIS US LLC] 7 Current NDC, Legacy NDC, 6 package rows 20241103_b6a02568-867b-4c7b-890f-5d28bf0b363d.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-2061-01 00574206101 1 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBE 1 tube 2009-01-07 0000-00-00 No No Current 0574-2061-30 00574206130 1 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBE 1 tube 2009-01-07 0000-00-00 No No Current 0574-2061-45 00574206145 1 TUBE in 1 CARTON (0574-2061-45) / 45 g in 1 TUBE 1 tube 2009-01-07 0000-00-00 No No Current