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 21 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort Armor Antifungal MedicatedTOLNAFTATERida LLC33994035-b429-4ead-8885-98e38b25059a2026-02-04WarningsExact identifier
application number: M005
BeamBalm FUNGL NAILTOLNAFTATE 1% FUNGL NAILJiangxi Yudexi Pharmaceutical Co., LTD49f72e97-2393-dca8-e063-6394a90a6f102026-02-03WarningsExact identifier
application number: M005
MARIANP FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.49d1dbc4-91be-1f5c-e063-6394a90a55ec2026-02-02WarningsExact identifier
application number: M005
Jorvinl Nail Fungus TreatmentUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.49d88844-9cb0-f575-e063-6394a90a0d2f2026-02-02WarningsExact identifier
application number: M005
FlyLeaf Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.49d8e823-b7a2-8c18-e063-6294a90a77452026-02-02WarningsExact identifier
application number: M005
BLDAXN FUNGUS NAIL PENUNDECYLENIC ACID, TOLNAFTATEGuangdong Quadrant Ecological Technology Co., Ltd.49e291e1-be83-8926-e063-6394a90a13c22026-02-02WarningsExact identifier
application number: M005
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
application number: M005
Alveora FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD49964c81-1c86-e1f5-e063-6394a90a7d082026-01-30WarningsExact identifier
application number: M005
Alveora NAIL FUNGUS TREATMENTALVEORA NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD49985b01-ef96-0d27-e063-6294a90ac1692026-01-30WarningsExact identifier
application number: M005
ProClearz Laser AntifungalTOLNAFTATERooftop Consumer Health, inc53648135-7b79-4775-993b-48fa1298b7472026-01-29WarningsExact identifier
application number: M005
Proclearz Professional Fungal ShieldTOLNAFTATERooftop Consumer health, inc51125209-c279-4abb-af07-500982651cab2026-01-29WarningsExact identifier
application number: M005
TheraCare Antifungal CreamTOLNAFTATEVeridian Healthcaree9478d74-c0d9-4b88-a474-b88d10f525712026-01-29WarningsExact identifier
application number: M005
BLDAXN NAIL REPAIR PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4992fbd8-f205-2ff6-e063-6394a90a7d062026-01-29WarningsExact identifier
application number: M005
Jock Itch Clotrimazole AntifungalCLOTRIMAZOLEWalMarta7677ad4-5239-40da-809a-501b91caedbf2026-01-29WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.401f4993-0200-f1fd-e063-6294a90a65892026-01-28WarningsExact identifier
application number: M005
Foot PowderMICONAZOLE NITRATEWalgreens Company137a493b-6ed5-d649-e063-6294a90ac4422026-01-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsExact identifier
application number: M005
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsExact identifier
application number: M005
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsExact 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