FDA.reportPublic FDA data

Fungi Nail Toe and Foot

Product NDC
55505-177
11-digit product format
555050177
Labeler code
55505
Product ID
55505-177_29be9a78-384b-4807-ab8b-1417d6e0e48f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kramer Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-25
Substance
TOLNAFTATE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fungi Nail Toe and Foot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup
2120579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3ae043b-dc97-449b-b099-70bdf8e92482Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-177-24Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-24Fungi Nail Toe and Foot15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION157
55505-177-26Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-26Fungi Nail Toe and Foot30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION307
55505-177-80Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-80Fungi Nail Toe and Foot30 mL in 1 BOTTLE, SPRAYSOLUTION307
55505-177-87Fungi Nail Toe and Foot2 in 1 PACKAGESOLUTION27
55505-177-87Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-177FUNGI NAIL TOE AND FOOT (TOLNAFTATE) SOLUTION [KRAMER LABORATORIES]6Current NDC, Legacy NDC, 8 package rows20250323_a3ae043b-dc97-449b-b099-70bdf8e92482.zip

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 1 of 50 · 984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-06WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-04WarningsExact 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
Maximum Strength Antifungal LiquidTOLNAFTATEMeijer Distribution Inc0b3eb169-b309-8c1a-e063-6294a90a726e2026-08-03WarningsExact identifier
application number: M005
ProCure Antifungal CreamMICONAZOLE NITRATE 2%Twin Med LLC39d55df5-8a8e-3a9b-e063-6294a90af20b2026-08-03WarningsExact identifier
application number: M005
MiratiFul Nail Fungus TreatmentTOLNAFTATETexas MiratiFul Enterprises Inc.35eb20e3-86d4-4bec-b572-3d5fe86ac74d2026-08-03WarningsExact identifier
application number: M005
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-07-27WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120579FUNGI-NAIL 1 % Topical Solution, Reformulated Mar 2019PSNa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 1 % Topical SolutionPSNa3ae043b-dc97-449b-b099-70bdf8e924827
2120579tolnaftate 10 MG/ML Topical Solution [Fungi-Nail Reformulated Mar 2019]SBDa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 10 MG/ML Topical SolutionSCDa3ae043b-dc97-449b-b099-70bdf8e924827
2120579Fungi-Nail Reformulated Mar 2019 1 % Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827
2120579Fungi-Nail Reformulated Mar 2019 10 MG/ML Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 1 % Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-177-24555050177241 BOTTLE, WITH APPLICATOR in 1 CARTON (55505-177-24) / 15 mL in 1 BOTTLE, WITH APPLICATOR2025-04-01NoNoCurrent
55505-177-26555050177261 BOTTLE, WITH APPLICATOR in 1 CARTON (55505-177-26) / 30 mL in 1 BOTTLE, WITH APPLICATOR2019-03-250000-00-00NoNoCurrent
55505-177-80555050177801 BOTTLE, SPRAY in 1 CARTON (55505-177-80) / 30 mL in 1 BOTTLE, SPRAY2022-12-100000-00-00NoNoCurrent
55505-177-87555050177872 CARTON in 1 PACKAGE (55505-177-87) / 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 30 mL in 1 BOTTLE, WITH APPLICATOR2 carton2019-12-27NoNoCurrent