Home NDC 54312-125 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 Ingredient Strength UNDECYLENIC ACID 5 g/100g ZINC UNDECYLENATE 18 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup 388VZ25DUR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435154 Internal RxNorm lookup 1435159 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54312-125-01 Derman Antifungal 25 g in 1 TUBE CREAM 25 24 54312-125-01 Derman Antifungal 1 in 1 CARTON CREAM 1 24 54312-125-02 Derman Antifungal 50 g in 1 TUBE CREAM 50 24 54312-125-02 Derman Antifungal 1 in 1 CARTON CREAM 1 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded UNDECYLENIC ACID ACTIVE INGREDIENT K3D86KJ24N DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 ZINC UNDECYLENATE ACTIVE INGREDIENT 388VZ25DUR DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 UNDECYLENIC ACID ACTIVE MOIETY K3D86KJ24N DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 POLYETHYLENE GLYCOL 500 INACTIVE INGREDIENT 761NX2Q08Y DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 SODIUM BISULFITE INACTIVE INGREDIENT TZX5469Z6I DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 4 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV DERMAN 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 NDC Dashboard title SPL version Validation Dashboard ZIP 54312-125 DERMAN ANTIFUNGAL (ZINC UNDECYLENATE) CREAM [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 21 Current NDC, Legacy NDC, 4 package rows 20241218_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 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54312-125-01 54312012501 1 TUBE in 1 CARTON (54312-125-01) / 25 g in 1 TUBE 1 tube 2013-08-12 0000-00-00 No No Current 54312-125-02 54312012502 1 TUBE in 1 CARTON (54312-125-02) / 50 g in 1 TUBE 1 tube 2013-08-12 0000-00-00 No No Current