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
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c67dd09-ab1f-4ccf-97b5-421356f64f22Available on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiclopiroxCICLOPIROXAcella Pharmaceuticals, LLC2c67dd09-ab1f-4ccf-97b5-421356f64f222026-06-19Warnings, Adverse reactionsExact identifier
ndc (product): 42192-714

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