FDA.reportPublic FDA data

Defense Antifungal Medicated Bar

Product NDC
70856-3581
11-digit product format
708563581
Labeler code
70856
Product ID
70856-3581_5b115704-9941-40ec-e063-6394a90a7d9b
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOAP
Route
TOPICAL
Labeler
Defense Soap LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-01
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Defense Antifungal Medicated Bar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
1807715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
812d78ea-a14a-e3a2-e053-2a91aa0a6ff5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70856-3581-3Defense Antifungal Medicated Bar119 g in 1 CARTONSOAP1197

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70856-3581DEFENSE ANTIFUNGAL MEDICATED BAR (TOLNAFTATE) SOAP [DEFENSE SOAP LLC]6Current NDC, Legacy NDC, 1 package rows20241004_812d78ea-a14a-e3a2-e053-2a91aa0a6ff5.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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT CARETOLNAFTATE 1% ANTIFUNGAL FOOT CAREWenzhou Yuyuan Pharmaceutical Co., Ltd.56b10492-894c-33e1-e063-6394a90a8c0f2026-07-17WarningsExact identifier
application number: M005
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsExact identifier
application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
application number: M005
DRAVYNOR BALANITIS RELIEF CreamMICONAZOLE NITRATE 2% BALANITIS RELIEF CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.56b76a52-0743-4fe6-e063-6294a90a98a82026-07-16WarningsExact identifier
application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream5% BENZOYL PEROXIDE FOLLICULITIS CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56c558fa-303f-fc52-e063-6394a90a72f02026-07-16WarningsExact identifier
application number: M005
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsExact identifier
application number: M005
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Tinea TreatmentCLEAR ROOT LABS TINEA TREATMENTAidance Scientic Inc., DBA Aidance Skincare & Topicals56a67bad-c677-d3b7-e063-6394a90ad2052026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Antifungal TreatmentCLEAR ROOT LABS ANTIFUNGAL TREATMENTAidance Scientific, Inc., DBA Aidance Skincare & Topicals5696bf23-230a-5f37-e063-6294a90a74132026-07-15WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL NAIL LiquidTOLNAFTATE 1% ANTIFUNGAL NAIL LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD56b17e50-bff1-5eb0-e063-6294a90a3c082026-07-15WarningsExact identifier
application number: M005
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsExact identifier
application number: M005
OAKDOLCHE Tea Tree Oil AntifungalTOLNAFTATENanjing Qiaotun Technology Co., Ltd.569dee15-e68d-220e-e063-6294a90af7c52026-07-14WarningsExact identifier
application number: M005
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
application number: M005
Aiilo NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.5689ac31-4d23-0fcc-e063-6394a90ac75b2026-07-13Exact identifier
application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.56519b25-f3c8-bcac-e063-6394a90af8792026-07-11WarningsExact identifier
application number: M005
Joymeey FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5652a22e-7b43-3c31-e063-6294a90ae4f12026-07-11WarningsExact identifier
application number: M005
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN812d78ea-a14a-e3a2-e053-2a91aa0a6ff57
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD812d78ea-a14a-e3a2-e053-2a91aa0a6ff57
1807715tolnaftate 1 % Medicated Bar SoapSY812d78ea-a14a-e3a2-e053-2a91aa0a6ff57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70856-3581-2708563581021 NOT APPLICABLE in 1 CARTON (70856-3581-2) > 119 g in 1 NOT APPLICABLE1 not applicable2019-02-010000-00-00NoNoCurrent
70856-3581-370856358103119 g in 1 CARTON (70856-3581-3) 119 g2019-02-01NoNoCurrent