FDA.reportPublic FDA data

Hermon Ringworm Treatment Body Wash

Product NDC
85398-028
11-digit product format
853980028
Labeler code
85398
Product ID
85398-028_48417be9-7cc1-e2f3-e063-6294a90aa2a2
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-27
Substance
TOLNAFTATE
Active strength
5 g/500g
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 Ringworm Treatment Body Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE5 g/500g

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
2689792Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48417be9-7cc0-e2f3-e063-6294a90aa2a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-028-01Hermon Ringworm Treatment Body Wash500 g in 1 BOTTLE, PUMPLIQUID5001
85398-028-01Hermon Ringworm Treatment Body Wash1 in 1 CARTONLIQUID11

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 3 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
TEATREEOILANTIFUNGALUNDECYLENIC ACID AND ZINC UNDECYLENATEFoshan Chancheng District Xuntou Electronic Commerce Co., Ltd5900904f-cf51-4398-e063-6394a90aca6c2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-12WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
RoyceDerm Athletes foot antifungal .cream.MICONAZOLE NITRATE 2%RoyceDerm LLC58d23aa0-497e-4ece-e063-6294a90aef662026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Lyssera Fungal Nail RenewalUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843c1a0-ab60-bd64-e063-6294a90af8582026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2689792tolnaftate 1 % Medicated Liquid SoapPSN48417be9-7cc0-e2f3-e063-6294a90aa2a21
2689792tolnaftate 10 MG/ML Medicated Liquid SoapSCD48417be9-7cc0-e2f3-e063-6294a90aa2a21
2689792tolnaftate 1 % Medicated Liquid SoapSY48417be9-7cc0-e2f3-e063-6294a90aa2a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85398-028-01853980028011 BOTTLE, PUMP in 1 CARTON (85398-028-01) / 500 g in 1 BOTTLE, PUMP2026-01-27NoNoCurrent