FDA.reportPublic FDA data

DERMAN ANTIFUNGAL

Product NDC
54312-325
Requested package NDC
54312-325-05
11-digit product format
543120325
Labeler code
54312
Product ID
54312-325_eea36358-3013-6ad4-e053-2a95a90a0a1e
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
SPRAY
Route
TOPICAL
Labeler
Compania Internacional de Comercio, S.A.P.I de C.V.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-21
Marketing end
0000-00-00
Substance
UNDECYLENIC ACID
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54312-32554312-325-05DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NDERMAN ANTIFUNGAL (UNDECYLENIC ACID) SPRAY [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NDERMAN ANTIFUNGAL (UNDECYLENIC ACID) SPRAY [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDERMAN ANTIFUNGAL (UNDECYLENIC ACID) SPRAY [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MDERMAN ANTIFUNGAL (UNDECYLENIC ACID) SPRAY [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54312-325-05543120325051 BOTTLE in 1 PACKAGE (54312-325-05) > 35 mL in 1 BOTTLE1 bottle2013-10-210000-00-00NoNoCurrent