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

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
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 37 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole 1% Athletes FootCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC9aba1345-ef47-4951-8448-a43d6696b6162025-07-07WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEStrategic Sourcing Services LLCd0c30c74-9472-4978-9623-8c7dbeb994112025-07-07WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
application number: M005
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
application number: M005
meijer Athletes FootCLOTRIMAZOLEMeijer Distribution Incfdb15cd8-6726-4150-9b9d-6ef3ee01a5d22025-07-02WarningsExact identifier
application number: M005
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
application number: M005
Rexall Jock ItchCLOTRIMAZOLEDollar General11427a79-f262-4702-9b2e-ec1955a9b2da2025-07-02WarningsExact identifier
application number: M005
Rexall Athletes FootCLOTRIMAZOLEDollar General664579a1-a5b0-4a4c-bff6-4347f3e1d3bb2025-07-02WarningsExact identifier
application number: M005
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
application number: M005
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
application number: M005
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYRite Aid Corporationaee58c44-5dba-8acb-e053-2a95a90a23af2025-06-21WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
application number: M005
TolnaftateJOCK ITCH POWDERRite Aid Corporationb6968587-45c2-d2f8-e053-2a95a90a84012025-06-21WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd67d1d65a-71d4-41fc-a71c-85a28ce6de0c2025-06-18WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd640df217-6982-441e-835a-dbe2031e732b2025-06-18WarningsExact identifier
application number: M005
EYELID WIPESEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD377fb842-aa78-ab2a-e063-6394a90a69f92025-06-13WarningsExact 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