FDA.reportPublic FDA data

Hermon Antifungal Cleansing Bar

Product NDC
85398-029
11-digit product format
853980029
Labeler code
85398
Product ID
85398-029_48b5d7b3-a135-ecdd-e063-6294a90a3213
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate 1%
Dosage form
SOAP
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-02
Substance
TOLNAFTATE
Active strength
4.52 g/452g
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
Hermon Antifungal Cleansing Bar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE4.52 g/452g

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
1807715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48b5d7b3-a134-ecdd-e063-6294a90a3213Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-029-01Hermon Antifungal Cleansing Bar452 g in 1 CARTONSOAP4521

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 40 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
application number: M005
ELLEN HAND SANITIZERETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA33077eab-e686-249d-e063-6394a90a1b6d2025-04-18WarningsExact identifier
application number: M005
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
application number: M005
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
application number: M005
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATETAGRID LLC32396be0-f74a-5483-e063-6294a90ab3ae2025-04-07WarningsExact identifier
application number: M005
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
application number: M005
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
application number: M005
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
application number: M005
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
application number: M005
1236-CS Antifungal Powder (Talc Free)1236-CCANTIFUNGAL POWDER(TALC FREE)Dynarex Corporation312ba573-4008-83e6-e063-6294a90a4a6d2025-03-25WarningsExact identifier
application number: M005
Antifungal Medicated BarTOLNAFTATERoyceDerm LLC31305ed2-a0a0-6d4c-e063-6294a90a6ba52025-03-25WarningsExact identifier
application number: M005
Forticept Antimicrobial Hydrogel Wound DressingBENZETHONIUM CHLORIDE, THYMOLLidan, Inccd5b7a72-1b87-434d-973e-071d2c8a438c2025-03-25WarningsExact identifier
application number: M005
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN48b5d7b3-a134-ecdd-e063-6294a90a32131
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD48b5d7b3-a134-ecdd-e063-6294a90a32131
1807715tolnaftate 1 % Medicated Bar SoapSY48b5d7b3-a134-ecdd-e063-6294a90a32131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-029-0185398002901452 g in 1 CARTON (85398-029-01) 452 g2026-02-02NoNoCurrent