FDA.reportPublic FDA data

HTRCSW FUNGAL NAIL RENEWAL

Product NDC
85248-217
11-digit product format
852480217
Labeler code
85248
Product ID
85248-217_571cb0b6-61fc-d9f7-e063-6294a90a0fe4
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25% TOENAIL FUNGUS PEN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-20
Substance
UNDECYLENIC ACID; TOLNAFTATE
Active strength
25; 1 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
HTRCSW FUNGAL NAIL RENEWAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL
TOLNAFTATE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
523bc484-511c-b603-e063-6394a90a55aeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-217-01HTRCSW FUNGAL NAIL RENEWAL3 in 1 BOXLIQUID31
85248-217-01HTRCSW FUNGAL NAIL RENEWAL5 mL in 1 TUBELIQUID51
85248-217-02HTRCSW FUNGAL NAIL RENEWAL10 mL in 1 TUBELIQUID101
85248-217-02HTRCSW FUNGAL NAIL RENEWAL2 in 1 BOXLIQUID21

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 44 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN523bc484-511c-b603-e063-6394a90a55ae1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD523bc484-511c-b603-e063-6394a90a55ae1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY523bc484-511c-b603-e063-6394a90a55ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-217-01852480217013 TUBE in 1 BOX (85248-217-01) / 5 mL in 1 TUBE3 tube2026-05-20NoNoCurrent
85248-217-02852480217022 TUBE in 1 BOX (85248-217-02) / 10 mL in 1 TUBE2 tube2026-05-20NoNoCurrent