FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX7.7 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19W019ZDRJ
Rxcui313941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-2061-01CICLOPIROX1 in 1 CARTONGEL17
0574-2061-01CICLOPIROX100 g in 1 TUBEGEL1007
0574-2061-30CICLOPIROX30 g in 1 TUBEGEL307
0574-2061-30CICLOPIROX1 in 1 CARTONGEL17
0574-2061-45CICLOPIROX1 in 1 CARTONGEL17
0574-2061-45CICLOPIROX45 g in 1 TUBEGEL457

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2061-01GM - Gram0574-2061805d208b-4eaa-45b7-80e7-c31ac988968c12013-02-13
0574-2061-30GM - Gram0574-2061411e57f7-eeee-412e-87ac-f61adbdbaf4312013-02-13
0574-2061-45GM - Gram0574-206125f310fe-7710-4fbb-b22f-7cb994352cfa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ECICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T794CICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX GEL [PADDOCK LABORATORIES, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-2061CICLOPIROX GEL [PADAGIS US LLC]7Current NDC, Legacy NDC, 6 package rows20241103_b6a02568-867b-4c7b-890f-5d28bf0b363d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313941ciclopirox 0.77 % Topical GelPSN9861c88d-528f-4e30-8c1e-56ac3afec76c104
313941ciclopirox 0.0077 MG/MG Topical GelSCD9861c88d-528f-4e30-8c1e-56ac3afec76c104
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY9861c88d-528f-4e30-8c1e-56ac3afec76c104
313941ciclopirox 0.77 % Topical GelSY9861c88d-528f-4e30-8c1e-56ac3afec76c104
313941ciclopirox 0.77 % Topical GelPSN808733e7-9402-4f9b-99ce-ca6d04ad4aee103
313941ciclopirox 0.77 % Topical GelPSN933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.0077 MG/MG Topical GelSCD808733e7-9402-4f9b-99ce-ca6d04ad4aee103
313941ciclopirox 0.0077 MG/MG Topical GelSCD933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY808733e7-9402-4f9b-99ce-ca6d04ad4aee103
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.77 % Topical GelSY808733e7-9402-4f9b-99ce-ca6d04ad4aee103
313941ciclopirox 0.77 % Topical GelSY933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.77 % Topical GelPSN51993bbb-f145-4662-8138-4db774cc0513101
313941ciclopirox 0.0077 MG/MG Topical GelSCD51993bbb-f145-4662-8138-4db774cc0513101
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY51993bbb-f145-4662-8138-4db774cc0513101
313941ciclopirox 0.77 % Topical GelSY51993bbb-f145-4662-8138-4db774cc0513101
313941ciclopirox 0.77 % Topical GelPSNb6a02568-867b-4c7b-890f-5d28bf0b363d7
313941ciclopirox 0.0077 MG/MG Topical GelSCDb6a02568-867b-4c7b-890f-5d28bf0b363d7
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSYb6a02568-867b-4c7b-890f-5d28bf0b363d7
313941ciclopirox 0.77 % Topical GelSYb6a02568-867b-4c7b-890f-5d28bf0b363d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-2061-01005742061011 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBE1 tube2009-01-070000-00-00NoNoCurrent
0574-2061-30005742061301 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBE1 tube2009-01-070000-00-00NoNoCurrent
0574-2061-45005742061451 TUBE in 1 CARTON (0574-2061-45) / 45 g in 1 TUBE1 tube2009-01-070000-00-00NoNoCurrent