FDA.reportPublic FDA data

Dr CANUSO fungal nail eraser

Product NDC
76348-410
11-digit product format
763480410
Labeler code
76348
Product ID
76348-410_350a8f7d-e332-0543-e063-6394a90a94c4
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate Oil
Dosage form
OIL
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-11
Substance
TOLNAFTATE
Active strength
.3 g/28g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76348-410-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76348-410-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76348-410-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-410-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-410-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-410-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-410-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Dr CANUSO fungal nail eraser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.3 g/28g

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
1362937Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2083f9ed-09d6-26e6-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-410-022025-05-13C16284748780-12cef2736-79c7-d83d-e063-dadaa90ab31fDr. CANUSO Fungal Nail Eraser
76348-410-022025-01-30C16284748780-12cef2736-79c7-d83d-e063-dadaa90ab31fDr. CANUSO Fungal Nail Eraser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-410-02Dr CANUSO fungal nail eraser14 g in 1 BOTTLE, GLASSOIL1410
76348-410-02Dr CANUSO fungal nail eraser1 in 1 BOXOIL110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
TOLNAFTATEACTIVE MOIETY06KB629TKVDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
CINNAMON LEAF OILINACTIVE INGREDIENTS92U8SQ71VDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)INACTIVE INGREDIENT587WKM3S9QDR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-410DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, LLC]10Current NDC, Legacy NDC, 2 package rows20250515_2083f9ed-09d6-26e6-e054-00144ff88e88.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 28 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cura Hongo AntifungalCLOTRIMAZOLEPharmadel LLCdf031309-2778-00cf-e053-2a95a90a5eea2025-11-17WarningsExact identifier
application number: M005
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltda7433f39-a8d9-4c78-864d-d7ef193a7daf2025-11-16WarningsExact identifier
application number: M005
Mint Blast Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLCf7fcac19-7b72-4b7a-a28e-669a0eebec9c2025-11-15WarningsExact identifier
application number: M005
Lavender Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC9db58924-a84d-4763-badb-b3aeb46e1ea62025-11-15WarningsExact identifier
application number: M005
Citrus Detox Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc2025-11-15WarningsExact identifier
application number: M005
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
application number: M005
Pharmlitalia Antifungal Medicated BodyTOLNAFTATEFoshan Sugar Max Cosmetics CO.,Ltd399302d2-0da4-4167-8884-b34a9aba86862025-11-10WarningsExact identifier
application number: M005
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
application number: M005
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
application number: M005
SKINHEAL ANTIFUNGALTOLNAFTATEZhejiang Dingtai Pharmaceutical Co., Ltd570ee9fb-a495-4a99-9215-0cd1bb2e02902025-11-10WarningsExact identifier
application number: M005
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
application number: M005
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
application number: M005
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
application number: M005
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL POWDER SPRAYPremier Brands of America Inc.38ccf19c-2290-ad99-e063-6394a90a54692025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL POWDER SPRAY WITH BAKING SODATarget Corporation37792b12-c3dc-558f-e063-6294a90a7e752025-11-06WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREETopco Associates LLC5f8ac6b7-c46c-226c-e053-2991aa0a96062025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYTopco Associates LLC3dd0df06-3c74-4c34-a69e-4240945f5fa52025-11-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362937tolnaftate 1 % Topical OilPSN2083f9ed-09d6-26e6-e054-00144ff88e8810
1362937tolnaftate 10 MG/ML Topical OilSCD2083f9ed-09d6-26e6-e054-00144ff88e8810
1362937tolnaftate 1 % Topical OilSY2083f9ed-09d6-26e6-e054-00144ff88e8810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76348-410-02763480410021 BOTTLE, GLASS in 1 BOX (76348-410-02) / 14 g in 1 BOTTLE, GLASS2015-08-110000-00-00NoNoCurrent