FDA.reportPublic FDA data

Derman Antifungal

Product NDC
54312-125
11-digit product format
543120125
Labeler code
54312
Product ID
54312-125_43fa85f0-78bd-9e8d-e063-6294a90ab9da
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC UNDECYLENATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Compania Internacional de Comercio, S.A.P.I de C.V.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-12
Substance
UNDECYLENIC ACID; ZINC UNDECYLENATE
Active strength
5; 18 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID5 g/100g
ZINC UNDECYLENATE18 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N, 388VZ25DUR
Rxcui1435154, 1435159

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-125-01Derman Antifungal25 g in 1 TUBECREAM2524
54312-125-01Derman Antifungal1 in 1 CARTONCREAM124
54312-125-02Derman Antifungal50 g in 1 TUBECREAM5024
54312-125-02Derman Antifungal1 in 1 CARTONCREAM124

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
ZINC UNDECYLENATEACTIVE INGREDIENT388VZ25DURDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
POLYETHYLENE GLYCOL 500INACTIVE INGREDIENT761NX2Q08YDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
WATERINACTIVE INGREDIENT059QF0KO0RDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVDERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54312-125DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]21Current NDC, Legacy NDC, 4 package rows20241218_0129d801-90f6-49fd-857f-27d6ba9fc66c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435159Derman Antifungal 5 % / 18 % Topical CreamPSN0129d801-90f6-49fd-857f-27d6ba9fc66c24
1435154undecylenic acid 5 % / zinc undecylenate 18 % Topical CreamPSN0129d801-90f6-49fd-857f-27d6ba9fc66c24
1435159undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical Cream [Derman]SBD0129d801-90f6-49fd-857f-27d6ba9fc66c24
1435154undecylenic acid 50 MG/ML / zinc undecylenate 180 MG/ML Topical CreamSCD0129d801-90f6-49fd-857f-27d6ba9fc66c24
1435159Derman Antifungal (undecylenic acid 5 % / zinc undecylenate 18 % ) Topical CreamSY0129d801-90f6-49fd-857f-27d6ba9fc66c24
1435154undecylenic acid 5 % / zinc undecylenate 18 % Topical CreamSY0129d801-90f6-49fd-857f-27d6ba9fc66c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54312-125-01543120125011 TUBE in 1 CARTON (54312-125-01) / 25 g in 1 TUBE1 tube2013-08-120000-00-00NoNoCurrent
54312-125-02543120125021 TUBE in 1 CARTON (54312-125-02) / 50 g in 1 TUBE1 tube2013-08-120000-00-00NoNoCurrent