Home NDC 0713-0638 Ciclopirox Olamine
Product NDC 0713-0638
11-digit product format 007130638
Labeler code 0713
Product ID 0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciclopirox Olamine
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA078463
Marketing category ANDA
Marketing start 2007-05-22
Substance CICLOPIROX OLAMINE
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 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 A078463-001 CICLOPIROX CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078463-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078463-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2010-12-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ciclopirox Olamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CICLOPIROX OLAMINE 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 50MD4SB4AP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309289 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0638-15 Ciclopirox Olamine 15 g in 1 TUBE CREAM 15 9 0713-0638-15 Ciclopirox Olamine 1 in 1 BOX CREAM 1 9 0713-0638-18 Ciclopirox Olamine 1 in 1 BOX CREAM 1 9 0713-0638-18 Ciclopirox Olamine 90 g in 1 TUBE CREAM 90 9 0713-0638-31 Ciclopirox Olamine 30 g in 1 TUBE CREAM 30 9 0713-0638-31 Ciclopirox Olamine 1 in 1 BOX CREAM 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ciclopirox Olamine ACTIVE INGREDIENT 50MD4SB4AP CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Ciclopirox ACTIVE MOIETY 19W019ZDRJ CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Lactic Acid INACTIVE INGREDIENT 33X04XA5AT CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Myristyl Alcohol INACTIVE INGREDIENT V42034O9PU CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Octyldodecanol INACTIVE INGREDIENT 461N1O614Y CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Sorbitan Monostearate INACTIVE INGREDIENT NVZ4I0H58X CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4 Water INACTIVE INGREDIENT 059QF0KO0R CICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0638 CICLOPIROX OLAMINE CREAM [COSETTE PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 6 package rows 20221117_5c585aa5-7d2d-e798-c0bd-d602574d643c.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 · 1 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 0713-0638-15 00713063815 1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE 1 tube 2007-05-22 0000-00-00 No No Current 0713-0638-18 00713063818 1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE 1 tube 2007-05-22 0000-00-00 No No Current 0713-0638-31 00713063831 1 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBE 1 tube 2007-05-22 0000-00-00 No No Current