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 9 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
application number: M005
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT LIQUIDWalgreens Company94f4f656-e8a3-4439-b53c-12be59dc8eac2026-06-20WarningsExact identifier
application number: M005
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreeTOLNAFTATERida LLC0c7a3b2d-8b1c-4130-86ad-892a591574802026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
application number: M005
Anytalk FUNGAL NAIL TREATMENTTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.54718558-376f-ed31-e063-6294a90a52202026-06-17WarningsExact identifier
application number: M005
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
application number: M005
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
application number: M005
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
application number: M005
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SolutionBIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTIONGuangxi Rise Biological Technology Co.,Ltd.5457a623-7812-e516-e063-6394a90a8bfd2026-06-15WarningsExact identifier
application number: M005
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
application number: M005
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a2317d2-e45b-1fe2-e063-6394a90a940d2026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a23c01b-492d-324b-e063-6394a90a73b12026-06-14WarningsExact identifier
application number: M005
HEALMUSZ Multi-PurposeTreatmentTOLNAFTATE 1% MULTI-PURPOSETREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a2421d8-a543-abb1-e063-6394a90afaa72026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a24b5ae-f86c-459f-e063-6394a90ac5c32026-06-14WarningsExact identifier
application number: M005
PUVIDA Helps WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4828d7-091b-7c8e-e063-6294a90af1362026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a484e3d-d653-2689-e063-6394a90a64ef2026-06-14WarningsExact 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