FDA.reportPublic FDA data

Tagrid Antifungal

Product NDC
85384-0013
11-digit product format
853840013
Labeler code
85384
Product ID
85384-0013_70b58b12-b8e6-4d3a-82e8-2a640febb388
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOAP
Route
TOPICAL
Labeler
TAGRID LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-09
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
Tagrid Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85384-0013-1Tagrid Antifungal113.4 g in 1 BOXSOAP113.43
85384-0013-2Tagrid Antifungal226.8 g in 1 BOXSOAP226.83
85384-0013-1Tagrid Antifungal Kit113.4 g in 1 BOXSOAP113.4 g10 mg in 1g2

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 14 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.51465ebf-3b5f-e2bf-e063-6394a90adaf22026-05-07WarningsExact identifier
application number: M005
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
application number: M005
QQE Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.510ff705-e2cb-b77b-e063-6394a90a9e722026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
application number: M005
NATURAL CURES FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD510a8df7-ea6d-d634-e063-6294a90aea532026-05-04WarningsExact identifier
application number: M005
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
application number: M005
Uauko Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.50d16854-ab90-d6cf-e063-6294a90a21b12026-05-02WarningsExact identifier
application number: M005
NAIL RENEWTOLNAFTATENailrenew Corpa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b52026-05-02WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZER SPRAYCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4934c20d-6295-aeb8-e063-6394a90adfeb2026-04-30WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4931f2e4-0fef-a8c7-e063-6394a90ac16e2026-04-30WarningsExact identifier
application number: M005
MINADCIN TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD50a9264e-aba0-0ae2-e063-6294a90acfff2026-04-30WarningsExact identifier
application number: M005
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.493120ee-0c5c-b704-e063-6394a90a8c192026-04-29WarningsExact identifier
application number: M005
ProBliva Antifungal Scrub .soap. BarTOLNAFTATE 1%CAVTECH HOLDING LLC5090a9ad-3df7-6699-e063-6394a90a72f72026-04-28WarningsExact identifier
application number: M005
FifthPulse Clotrimazole AntifungalCLOTRIMAZOLEWeCare Products LLC9f5ea297-5a25-42cc-bd47-4159108b00232026-04-27WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PENJiangxi Yudexi Pharmaceutical Co., LTD501cf54a-31da-6db2-e063-6394a90a65f82026-04-23WarningsExact identifier
application number: M005
Medicated Athletes Foot PowderMICONAZOLE NITRATEPremier Brands of America Inc.38cc0c66-82b5-bac4-e063-6294a90a23f02026-04-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN7aa42827-59c2-4926-a3a2-e60dd219eb413
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD7aa42827-59c2-4926-a3a2-e60dd219eb413
1807715tolnaftate 1 % Medicated Bar SoapSY7aa42827-59c2-4926-a3a2-e60dd219eb413
1807715tolnaftate 1 % Medicated Bar SoapPSN73d937da-efa9-4095-84ea-4eeeab1195462
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD73d937da-efa9-4095-84ea-4eeeab1195462
1807715tolnaftate 1 % Medicated Bar SoapSY73d937da-efa9-4095-84ea-4eeeab1195462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85384-0013-185384001301113.4 g in 1 BOX (85384-0013-1) 113.4 g2025-06-09NoNoCurrent
85384-0013-285384001302226.8 g in 1 BOX (85384-0013-2) 226.8 g2025-12-09NoNoCurrent
85384-0013-385384001303124.74 g in 1 BOX (85384-0013-3) 124.74 g2025-06-09NoNoCurrent
85384-0013-485384001304249.48 g in 1 BOX (85384-0013-4) 249.48 g2025-12-09NoNoCurrent