Dr. Canuso foot repair serum

Product NDC
76348-409
11-digit product format
763480409
Labeler code
76348
Product ID
76348-409_350b8fbb-d869-9503-e063-6394a90a9eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate serum
Dosage form
LOTION
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-20
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 packagepackage76348-409-02IInactivated 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 packagepackage76348-409-02IInactivated 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 packagepackage76348-409-02IInactivated 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 packagepackage76348-409-02IInactivated 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 packagepackage76348-409-02UExcluded 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 packagepackage76348-409-02UExcluded 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 packagepackage76348-409-02UExcluded 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 foot repair serum
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
283693Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fcc52c5-7030-13cb-e054-00144ff8d46cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-409-022025-05-13C16284748780-12cef2736-5c2d-d83d-e063-dadaa90ab31fDr. Canuso foot repair serum TM
76348-409-022025-01-30C16284748780-12cef2736-5c2d-d83d-e063-dadaa90ab31fDr. Canuso foot repair serum TM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-409-02Dr. Canuso foot repair serum28 g in 1 BOTTLE, PUMPLOTION2817
76348-409-02Dr. Canuso foot repair serum1 in 1 BOXLOTION117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
TOLNAFTATEACTIVE MOIETY06KB629TKVDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
2-HYDROXYETHYL ACRYLATEINACTIVE INGREDIENT25GT92NY0CDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
ACETYLATED LANOLIN ALCOHOLSINACTIVE INGREDIENTSNN716810PDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
CETYL ACETATEINACTIVE INGREDIENT4Q43814HXSDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
PEG-12 DIMETHICONE (300 CST)INACTIVE INGREDIENTZEL54N6W95DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
SODIUM ACRYLOYLDIMETHYLTAURATEINACTIVE INGREDIENT2T9Q6EKI0GDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
SQUALANEINACTIVE INGREDIENTGW89575KF9DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1UDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RDR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-409DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, LLC]17Current NDC, Legacy NDC, 2 package rows20250515_1fcc52c5-7030-13cb-e054-00144ff8d46c.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 7 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact identifier
application number: M005
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
Cysndra Ringworm CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangzhou Xinhongda Trading Service Co., Ltd.55ed83eb-0e67-e516-e063-6394a90af4432026-07-06WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
Cysndra Fungal Nail RevitalizerUNDECYLENIC ACIDGuangzhou Xinhongda Trading Service Co., Ltd.55e9f1cf-4055-6c27-e063-6394a90ac3732026-07-05WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283693tolnaftate 1 % Topical LotionPSN1fcc52c5-7030-13cb-e054-00144ff8d46c17
283693tolnaftate 10 MG/ML Topical LotionSCD1fcc52c5-7030-13cb-e054-00144ff8d46c17
283693tolnaftate 1 % Topical LotionSY1fcc52c5-7030-13cb-e054-00144ff8d46c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76348-409-02763480409021 BOTTLE, PUMP in 1 BOX (76348-409-02) / 28 g in 1 BOTTLE, PUMP2015-08-200000-00-00NoNoCurrent