FDA.reportPublic FDA data

Gemachlich ZuHause Fungal Nail Revitalizer

Product NDC
76986-007
11-digit product format
769860007
Labeler code
76986
Product ID
76986-007_37332cdf-7172-42cc-e063-6394a90a0fcf
Type
HUMAN OTC DRUG
Nonproprietary name
Gemachlich ZuHause Fungal Nail Revitalizer
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangdong Quadrant Ecological Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-10
Substance
UNDECYLENIC ACID
Active strength
11 g/100mL
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
Gemachlich ZuHause Fungal Nail Revitalizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID11 g/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099259Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37332cdf-7171-42cc-e063-6394a90a0fcfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-007-01Gemachlich ZuHause Fungal Nail Revitalizer3 in 1 BOXLIQUID31
76986-007-01Gemachlich ZuHause Fungal Nail Revitalizer4 mL in 1 TUBELIQUID41
76986-007-02Gemachlich ZuHause Fungal Nail Revitalizer30 mL in 1 BOTTLELIQUID301

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 33 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
application number: M005
SKIN TAG WART AND CORN REMOVERSALICYLIC ACIDZhenping Renren Industry Co., Ltd.3e6dad69-b301-f7dc-e063-6394a90ad3802025-09-14WarningsExact identifier
application number: M005
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
application number: M005
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
application number: M005
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.3e7d22b0-2f57-fcac-e063-6394a90aefd92025-09-10WarningsExact identifier
application number: M005
Amerfresh Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltdcdc4f0ff-07bd-47c8-850b-1698308bb6602025-09-09WarningsExact identifier
application number: M005
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
application number: M005
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
application number: M005
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
application number: M005
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
application number: M005
CaseysBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.a29d6c19-01aa-45b0-92cd-3f1148bad4f82025-08-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
application number: M005
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsExact identifier
application number: M005
femmesil Ultra TherapyCLOTRIMAZOLEAidance Scientific, Inc.3d36794a-07d0-860c-e063-6294a90a6e8f2025-08-25WarningsExact identifier
application number: M005
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLC6b74d405-42d6-4c46-ba78-3007d1e8ffb82025-08-23WarningsExact identifier
application number: M005
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
application number: M005
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099259undecylenic acid 11 % Topical SolutionPSN37332cdf-7171-42cc-e063-6394a90a0fcf1
1099259undecylenic acid 110 MG/ML Topical SolutionSCD37332cdf-7171-42cc-e063-6394a90a0fcf1
1099259undecylenic acid 11 % Topical SolutionSY37332cdf-7171-42cc-e063-6394a90a0fcf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-007-01769860007013 TUBE in 1 BOX (76986-007-01) / 4 mL in 1 TUBE3 tube2025-06-10NoNoCurrent
76986-007-027698600070230 mL in 1 BOTTLE (76986-007-02) 30 ml2025-06-10NoNoCurrent