FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53145-219-03IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53145-219-03IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-219-03EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
IngredientStrength
UNDECYLENIC ACID20 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4adb7b0-59b4-4b3c-9b0e-1869bb543174Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-219-032023-07-28C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M
53145-219-032021-04-17C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M
53145-219-032020-01-31C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-219-03HongocuraM60 mL in 1 BOTTLE, SPRAYSPRAY608
53145-219-03HongocuraM1 in 1 CARTONSPRAY18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NHONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.]2
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NHONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHONGOCURA M (UNDECYLENIC ACID) LIQUID [MENPER DISTRIBUTORS, INC.]2

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 32 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arflom Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.413e76b5-263c-62fa-e063-6294a90a92142025-10-15WarningsExact identifier
application number: M005
VTROUY Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.413f6399-dda1-8dd9-e063-6394a90a573d2025-10-15WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Incf647308a-ea6c-47a9-a124-60e7888afac22025-10-14WarningsExact identifier
application number: M005
Tripenicol SUNDECYLENIC ACIDTrifluent Pharma LLCb57500e1-ea6f-4043-99d6-326a7eb57f2f2025-10-14WarningsExact identifier
application number: M005
TriTolnacide CTOLNAFTATETrifluent Pharma LLC12b53c2a-b073-43db-88d9-ede8300626aa2025-10-14WarningsExact identifier
application number: M005
Tritolnacide STOLNAFTATETrifluent Pharma LLCb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d82025-10-14WarningsExact identifier
application number: M005
Tripenicol CUNDECYLENIC ACIDTrifluent Pharma LLC0a7477da-370f-451f-8993-8c675c1686962025-10-14WarningsExact identifier
application number: M005
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
application number: M005
seebeellar antifungal cream 2% miconazoleSEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLEGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd40c491f6-43b4-534e-e063-6294a90a73d62025-10-09WarningsExact identifier
application number: M005
Hermon Antifungal Jock Itch Body WashTOLNAFTATE 1%Beautivity LLC409ef5c0-dfe5-f26a-e063-6294a90a27452025-10-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
application number: M005
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
application number: M005
antibacterial body washSILVERGuangdong Quaker Daily Chemical Co., LTD3fff8d3e-1944-4813-e063-6294a90a1a1d2025-09-30WarningsExact identifier
application number: M005
Tobcharm Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.4001247d-4704-8786-e063-6394a90a083a2025-09-30WarningsExact identifier
application number: M005
Silka AntifungalTOLNAFTATEGenomma Lab USAfb1dc636-837f-491c-97c1-e74288aebc272025-09-30WarningsExact identifier
application number: M005
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.3d48a3c6-b7d6-6794-e063-6294a90afff92025-09-29WarningsExact identifier
application number: M005
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
application number: M005
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe861cc-c972-a328-e063-6294a90afc8f2025-09-28WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal Foot CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe8fc55-bd64-a4a8-e063-6294a90ad18c2025-09-28WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-219-03531450219031 BOTTLE, SPRAY in 1 CARTON (53145-219-03) / 60 mL in 1 BOTTLE, SPRAY2020-04-060000-00-00NoNoCurrent