FDA.reportPublic FDA data

Derman Antifungal

Product NDC
54312-230
11-digit product format
543120230
Labeler code
54312
Product ID
54312-230_4c4d682d-dea0-cfe0-e063-6394a90a741e
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Compania Internacional de Comercio, S.A.P.I. de C.V.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-13
Substance
TOLNAFTATE
Active strength
10 mg/g
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
Derman Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5784a783-1056-4d50-8d87-2df4f8e16b09Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-230-01Derman Antifungal130 g in 1 BOTTLE, SPRAYAEROSOL, POWDER1303

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 19 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProClearz Maximum Strength Fungal Shield Brush-on AntifungalTOLNAFTATERooftop Consumer Health, Inc.4d451e87-c25b-49cf-92b8-747b053930c22026-03-02WarningsExact identifier
application number: M005
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLCe0a2a907-9c3a-4c4e-e053-2995a90abb912026-03-01WarningsExact identifier
application number: M005
FOLUPIA FUNGAL NAIL RENEWALFOLUPIA FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4bcacd53-9446-67ec-e063-6294a90a209e2026-02-27WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.d6f5c6b5-5e56-462f-8c47-7986ce53669d2026-02-25WarningsExact identifier
application number: M005
Lakeim FUNGAL NAIL RENEWAL KitFUNGAL NAIL RENEWAL KITGuangzhou Jingliang Cosmetics Co., Ltd.4b6aae50-b219-beee-e063-6394a90ab4152026-02-22WarningsExact identifier
application number: M005
Hermon Jock Itch spray.MICONAZOLE NITRATE 2%Beautivity LLC4b633528-667a-f34e-e063-6294a90a2b3d2026-02-21WarningsExact identifier
application number: M005
Lakeim Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.4b23c3a6-51da-7875-e063-6394a90a14672026-02-18WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.4b113f31-1a82-a3ca-e063-6394a90a32312026-02-17WarningsExact identifier
application number: M005
Hermon Ringworm Antifungal soap.CLOTRIMAZOLE 1%Beautivity LLC48405a7c-14cd-b3a0-e063-6394a90a9fc92026-02-13WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal soap.TEA TREE OIL ANTIFUNGAL SOAPRoyceDerm LLC3a6d1e32-a38b-3dde-e063-6394a90a88f32026-02-13WarningsExact identifier
application number: M005
Happy Nuts Jock Itch PowderMICONAZOLE NITRATESuit Up Brands LLC42e2d9df-6537-b3a1-e063-6394a90a47b72026-02-13WarningsExact identifier
application number: M005
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
application number: M005
Hermon Ringworm Treatment KitMICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%Beautivity LLC4a9d9c6e-0e0f-d539-e063-6294a90acb572026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Antifungal Soothing CreamANTIFUNGAL SOOTHING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a077685-4177-bc0d-e063-6294a90a461b2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.3a08ec6c-03ae-b9e5-e063-6394a90a0afb2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN5784a783-1056-4d50-8d87-2df4f8e16b093
705934tolnaftate 0.01 MG/MG Powder SpraySCD5784a783-1056-4d50-8d87-2df4f8e16b093
705934tolnaftate 1 % Powder SpraySY5784a783-1056-4d50-8d87-2df4f8e16b093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54312-230-0154312023001130 g in 1 BOTTLE, SPRAY (54312-230-01) 130 g2025-11-13NoNoCurrent