FDA.reportPublic FDA data

CIDACIN Antifungal Treatment

Product NDC
51151-000
11-digit product format
511510000
Labeler code
51151
Product ID
51151-000_0973a822-e694-feb3-e063-6294a90ab132
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Pedicis Research LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-07
Substance
TOLNAFTATE
Active strength
1 g/100mL
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
CIDACIN Antifungal Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

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
1300375Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd53a9e3-65c8-4834-8e23-a2a928b83a66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51151-000-01CIDACIN Antifungal Treatment15 mL in 1 BOTTLESOLUTION156
51151-000-01CIDACIN Antifungal Treatment1 in 1 CARTONSOLUTION16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVCIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
TOLNAFTATEACTIVE MOIETY06KB629TKVCIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698HCIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0CIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2
POVIDONE-IODINEINACTIVE INGREDIENT85H0HZU99MCIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51151-000CIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]6Current NDC, Legacy NDC, 2 package rows20231106_bd53a9e3-65c8-4834-8e23-a2a928b83a66.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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300375CIDACIN 1 % Topical SolutionPSNbd53a9e3-65c8-4834-8e23-a2a928b83a666
313423tolnaftate 1 % Topical SolutionPSNbd53a9e3-65c8-4834-8e23-a2a928b83a666
1300375tolnaftate 10 MG/ML Topical Solution [Cidacin]SBDbd53a9e3-65c8-4834-8e23-a2a928b83a666
313423tolnaftate 10 MG/ML Topical SolutionSCDbd53a9e3-65c8-4834-8e23-a2a928b83a666
1300375Cidacin 1 % Topical SolutionSYbd53a9e3-65c8-4834-8e23-a2a928b83a666
1300375Cidacin 10 MG/ML Topical SolutionSYbd53a9e3-65c8-4834-8e23-a2a928b83a666
313423tolnaftate 1 % Topical SolutionSYbd53a9e3-65c8-4834-8e23-a2a928b83a666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51151-000-01511510000011 BOTTLE in 1 CARTON (51151-000-01) / 15 mL in 1 BOTTLE1 bottle2017-02-050000-00-00NoNoCurrent