FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT kit .liquid.

Product NDC
87870-001
11-digit product format
878700001
Labeler code
87870
Product ID
87870-001_56c93390-ee08-4f78-e063-6394a90add42
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudolarix Amabilis Bark 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
GETHSEMANE BRANCH CORPORATION
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-07
Substance
SOPHORA FLAVESCENS ROOT; STEMONA JAPONICA ROOT; DICTAMNUS DASYCARPUS ROOT BARK; SALICYLIC ACID; COPTIS CHINENSIS ROOT; ATRACTYLODES LANCEA ROOT; BORNEOL; PSEUDOLARIX AMABILIS BARK
Active strength
1.5; 2; 1.5; 1; 1; 1; 1.5; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
FUNGAL NAIL TREATMENT kit .liquid.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOPHORA FLAVESCENS ROOT1.5 g/100mL
STEMONA JAPONICA ROOT2 g/100mL
DICTAMNUS DASYCARPUS ROOT BARK1.5 g/100mL
SALICYLIC ACID1 g/100mL
COPTIS CHINENSIS ROOT1 g/100mL
ATRACTYLODES LANCEA ROOT1 g/100mL
BORNEOL1.5 g/100mL
PSEUDOLARIX AMABILIS BARK1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IYR6K8KQ5KInternal UNII lookup
FXG254HF10Internal UNII lookup
LA97176ILSInternal UNII lookup
O414PZ4LPZInternal UNII lookup
CXS4LJR7ELInternal UNII lookup
CAZ6282J2OInternal UNII lookup
M89NIB437XInternal UNII lookup
49G13A93VEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56c93390-ee07-4f78-e063-6394a90add42Available on FDA.report

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 49 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87870-001-018787000010115 mL in 1 BOTTLE (87870-001-01) 15 ml2026-08-07NoNoCurrent