FDA.reportPublic FDA data

Ciclopirox

Product NDC
42192-714
11-digit product format
421920714
Labeler code
42192
Product ID
42192-714_0fa6cf7e-6dc3-44a9-b1d1-f30e4feb367c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
KIT
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-10-10
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui309291

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
42192-714-01Ciclopirox1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-714-01ML - Milliliter42192-71403a8e27c-c626-455e-b9b2-a1372d690aa212013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLOPIROXACTIVE INGREDIENT19W019ZDRJCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
CICLOPIROXACTIVE MOIETY19W019ZDRJCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)INACTIVE INGREDIENT389H2R62BDCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941CICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662CICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%)INACTIVE INGREDIENT2Q40985DRMCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
UREAINACTIVE INGREDIENT8W8T17847WCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-714CICLOPIROX KIT [ACELLA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240125_2c67dd09-ab1f-4ccf-97b5-421356f64f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309291ciclopirox 8 % Topical SolutionPSN2c67dd09-ab1f-4ccf-97b5-421356f64f224
309291ciclopirox 80 MG/ML Topical SolutionSCD2c67dd09-ab1f-4ccf-97b5-421356f64f224
309291ciclopirox 8 % (nail lacquer) Topical SolutionSY2c67dd09-ab1f-4ccf-97b5-421356f64f224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-714-01421920714011 KIT in 1 CARTON (42192-714-01) * 6.6 mL in 1 BOTTLE, WITH APPLICATOR * 28 mL in 1 BOTTLE1 kit2011-10-100000-00-00NoNoCurrent