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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Derman Antifungal
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup
388VZ25DURInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1435154Internal RxNorm lookup
1435159Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0129d801-90f6-49fd-857f-27d6ba9fc66cAvailable on FDA.report

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

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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005

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