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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact 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