FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX OLAMINE7.7 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50MD4SB4AP
Rxcui309289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0638-15Ciclopirox Olamine15 g in 1 TUBECREAM159
0713-0638-15Ciclopirox Olamine1 in 1 BOXCREAM19
0713-0638-18Ciclopirox Olamine1 in 1 BOXCREAM19
0713-0638-18Ciclopirox Olamine90 g in 1 TUBECREAM909
0713-0638-31Ciclopirox Olamine30 g in 1 TUBECREAM309
0713-0638-31Ciclopirox Olamine1 in 1 BOXCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0638-15GM - Gram0713-0638b4b88e48-9cc8-4196-8807-1952b444e20c12012-07-24
0713-0638-18GM - Gram0713-0638f009d209-3331-48d0-abfb-210c129feb0e12012-07-24
0713-0638-31GM - Gram0713-0638517a650a-a730-4a95-a782-cfde688ebbed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ciclopirox OlamineACTIVE INGREDIENT50MD4SB4APCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
CiclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Lactic AcidINACTIVE INGREDIENT33X04XA5ATCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Mineral OilINACTIVE INGREDIENTT5L8T28FGPCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Myristyl AlcoholINACTIVE INGREDIENTV42034O9PUCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
OctyldodecanolINACTIVE INGREDIENT461N1O614YCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX OLAMINE (CICLOPIROX OLAMINE) CREAM [G&W LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0638CICLOPIROX OLAMINE CREAM [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 6 package rows20221117_5c585aa5-7d2d-e798-c0bd-d602574d643c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamPSN5c585aa5-7d2d-e798-c0bd-d602574d643c9
309289ciclopirox 7.7 MG/ML Topical CreamSCD5c585aa5-7d2d-e798-c0bd-d602574d643c9
309289ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical CreamSY5c585aa5-7d2d-e798-c0bd-d602574d643c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0638-15007130638151 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE1 tube2007-05-220000-00-00NoNoCurrent
0713-0638-18007130638181 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE1 tube2007-05-220000-00-00NoNoCurrent
0713-0638-31007130638311 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBE1 tube2007-05-220000-00-00NoNoCurrent