Home NDC 54312-925-01 DERMAN ANTIFUNGAL
Product NDC 54312-925
Requested package NDC 54312-925-01
11-digit product format 543120925
Labeler code 54312
Product ID 54312-925_eeb288a5-5442-c08c-e053-2a95a90a8fcc
Type HUMAN OTC DRUG
Nonproprietary name ZINC UNDECYLENATE, UNDECYLENIC ACID
Dosage form POWDER
Route TOPICAL
Labeler Compania Internacional de Comercio, S.A.P.I. de C.V.
Application part333C
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-09-30
Marketing end 0000-00-00
Substance UNDECYLENIC ACID; ZINC UNDECYLENATE
Active strength 2 g/100g; g/100g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded UNDECYLENIC ACID ACTIVE INGREDIENT K3D86KJ24N DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2 ZINC UNDECYLENATE ACTIVE INGREDIENT 388VZ25DUR DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2 UNDECYLENIC ACID ACTIVE MOIETY K3D86KJ24N DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV DERMAN ANTIFUNGAL (ZINC UNDECYLENATE, UNDECYLENIC ACID) POWDER [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54312-925-01 54312092501 1 BOTTLE in 1 PACKAGE (54312-925-01) > 80 g in 1 BOTTLE 1 bottle 2017-12-26 0000-00-00 No No Current