Home NDC 53145-219 Hongocura
Product NDC 53145-219
11-digit product format 531450219
Labeler code 53145
Product ID 53145-219_3a8a5464-a254-ca2c-e063-6294a90aa0fe
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid
Dosage form SPRAY
Route TOPICAL
Labeler MENPER DISTRIBUTORS, INC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-06
Substance UNDECYLENIC ACID
Active strength 20 mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-219-03 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-219-03 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-219-03 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Hongocura
Brand name suffix M
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 20 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-219-03 HongocuraM 60 mL in 1 BOTTLE, SPRAY SPRAY 60 8 53145-219-03 HongocuraM 1 in 1 CARTON SPRAY 1 8
DailyMed Socrata Ingredients# 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 41 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 1236-CS Antifungal Powder (Talc Free) 1236-CCANTIFUNGAL POWDER(TALC FREE) Dynarex Corporation 312ba573-4008-83e6-e063-6294a90a4a6d 2025-03-25 Warnings Exact identifier application number: M005 Antifungal Medicated Bar TOLNAFTATE RoyceDerm LLC 31305ed2-a0a0-6d4c-e063-6294a90a6ba5 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antimicrobial Hydrogel Wound Dressing BENZETHONIUM CHLORIDE, THYMOL Lidan, Inc cd5b7a72-1b87-434d-973e-071d2c8a438c 2025-03-25 Warnings Exact identifier application number: M005 Forticept HP Antiseptic Wound Cleanser BENZALKONIUM CHLORIDE, ALLANTOIN Lidan, inc. 41bb46ee-edce-4e1b-bcfd-5c5729e1eb15 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Gel CLOTRIMAZOLE Lidan, Inc. 1b5851fc-ae73-4e54-bb62-3ff928628b97 2025-03-25 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Preferred Pharmaceuticals Inc. 14d2a661-a490-41ca-b84f-f2be3bc271b4 2025-03-24 Warnings Exact identifier application number: M005 Dermatin Antifungal CLOTRIMAZOLE Melaleuca, Inc. e993fa3b-1d85-46b7-bda5-ed875be74c4e 2025-03-20 Warnings Exact identifier application number: M005 1% ketoconazole KETOCONAZOLE TAGRID LLC 30b75584-3a1e-c125-e063-6294a90acaa7 2025-03-19 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Cream CLOTRIMAZOLE Lidan, Inc. 17abeb4d-b211-4b8c-a9d2-4c7baba2450c 2025-03-07 Warnings Exact identifier application number: M005 Terramed Just Think Comfort Antifungal Medicated Body Wipes TOLNAFTATE Rida LLC 34577389-8e5d-49ab-a208-9c87b6f3cec4 2025-03-06 Warnings Exact identifier application number: M005 Athletes Foot MICONAZOLE NITRATE Rida LLC 85e98ef8-75c3-4be1-b59f-40b5312e2137 2025-03-06 Warnings Exact identifier application number: M005 SOUTH BEACH MULTI-PURPOSE NAIL REPAIR UNDECYLENIC ACID SOUTH BEACH HAIR CARE PROFESIONAL INC 2fb0110c-b275-2a17-e063-6394a90a2d30 2025-03-06 Warnings Exact identifier application number: M005 DG Health Athletes Foot CLOTRIMAZOLE Dolgencorp, Inc. 20370b32-21ad-4362-9b46-c6149c907231 2025-02-28 Warnings Exact identifier application number: M005 Family Wellness Clotrimazole 1 Anti Fungal Cream CLOTRIMAZOLE Family Dollar Stores, Inc 0667dd81-5633-494e-857e-45fa276fe72c 2025-02-25 Warnings Exact identifier application number: M005 Family Wellness Athletes Foot Tolnaftate 1 Cream TOLNAFTATE Family Dollar Stores, Inc f72b5bcd-8834-4da9-aa74-78992ec2838f 2025-02-25 Warnings Exact identifier application number: M005 ANTIFUNGAL MEDICATED BODY WASH TOLNAFTATE Rida LLC e3ebce6f-88ca-4100-ac79-d300f44e4891 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX AF TOLNAFTATE The Sisquoc Healthcare Corporation f6cf5315-6678-486c-85b2-d4b3f748600e 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX JOCK ITCH TREATMENT TOLNAFTATE The Sisquoc Healthcare Corporation b2ce1c25-93d5-441f-9b3b-68ae46400c2c 2025-02-25 Warnings Exact identifier application number: M005 Miconazole Nitrate MICONAZOLE NITRATE A-S Medication Solutions bf131f33-3ab2-4f43-add5-920e78ac36a7 2025-02-24 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Preferred Pharmaceuticals Inc. 0052992a-819c-4c55-bd88-201a09a3573a 2025-02-21 Warnings Exact identifier application number: M005
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-219-03 53145021903 1 BOTTLE, SPRAY in 1 CARTON (53145-219-03) / 60 mL in 1 BOTTLE, SPRAY 2020-04-06 0000-00-00 No No Current