FDA.reportPublic FDA data

Hongocura

Product NDC
53145-017
11-digit product format
531450017
Labeler code
53145
Product ID
53145-017_3a8931c9-1449-06ea-e063-6294a90a1df4
Type
HUMAN OTC DRUG
Nonproprietary name
undecylenic acid, zinc undecylenate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
MENPER DISTRIBUTORS, INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-09
Substance
UNDECYLENIC ACID; ZINC UNDECYLENATE
Active strength
5; 20 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Hongocura
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID5 g/100g
ZINC UNDECYLENATE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup
388VZ25DURInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313552Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c69b735e-0ffe-4328-bd9f-3c1ac6798c08Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-017-282023-07-28C16284748780-10191ceaa-60fd-198a-e063-dbdaa90aec3eHongocura ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-017-28Hongocura28 g in 1 TUBEOINTMENT283
53145-017-28Hongocura1 in 1 CARTONOINTMENT13

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 25 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005
TolnaftateODOR CONTROL POWDER SPRAYWalgreen Companya113f568-bd20-4f02-8e09-1b8223a0a9fa2025-12-16WarningsExact identifier
application number: M005
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
application number: M005
TEA TREE Oil ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD45bd3ad0-a0d1-314f-e063-6394a90a9a3a2025-12-12WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEMeijer Distribution Inc03fd2680-0040-aa8c-e063-6294a90a090f2025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
application number: M005
PedikleerTOLNAFTATERising Pharma Holdings, Inc.83396c51-7107-4d98-9d80-ebf6584f4dc82025-12-11WarningsExact identifier
application number: M005
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
application number: M005
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%UNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.457f819b-0850-a97c-e063-6394a90ac3682025-12-09WarningsExact identifier
application number: M005
NAIL REPAIR PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd45814b84-0e51-6c9d-e063-6394a90a29052025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313552undecylenic acid 5 % / zinc undecylenate 20 % Topical OintmentPSNc69b735e-0ffe-4328-bd9f-3c1ac6798c083
313552undecylenic acid 0.05 MG/MG / zinc undecylenate 0.2 MG/MG Topical OintmentSCDc69b735e-0ffe-4328-bd9f-3c1ac6798c083
313552undecylenic acid 5 % / zinc undecylenate 20 % Topical OintmentSYc69b735e-0ffe-4328-bd9f-3c1ac6798c083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-017-28531450017281 TUBE in 1 CARTON (53145-017-28) / 28 g in 1 TUBE1 tube2018-10-090000-00-00NoNoCurrent