FDA.reportPublic FDA data

Tea Tree Oil Foot Soak and Body Soak

Product NDC
83691-003
11-digit product format
836910003
Labeler code
83691
Product ID
83691-003_6a4e3e56-e905-4ce8-9372-0c873db9b901
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Undecylenate
Dosage form
GRANULE
Route
TOPICAL
Labeler
SANSAR, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-28
Substance
ZINC UNDECYLENATE
Active strength
10 g/100g
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
Tea Tree Oil Foot Soak and Body Soak
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC UNDECYLENATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
388VZ25DURInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c43816ac-2228-43ce-ba45-80cf3a7788f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-003-01Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-02Tea Tree Oil Foot Soak and Body Soak2 in 1 BAGGRANULE21
83691-003-02Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-03Tea Tree Oil Foot Soak and Body Soak453 g in 1 POUCHGRANULE4531
83691-003-03Tea Tree Oil Foot Soak and Body Soak4 in 1 BAGGRANULE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-003TEA TREE OIL FOOT SOAK AND BODY SOAK (ZINC UNDECYLENATE) GRANULE [SANSAR, LLC]1Current NDC, 5 package rows20250331_c43816ac-2228-43ce-ba45-80cf3a7788f2.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 10 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Beilloso Hyaluronic AcidCLOTRIMAZOLE 1 PERCENT HYALURONIC ACIDJiangxi Yudexi Pharmaceutical Co., LTD4a712797-c992-dd8e-e063-6294a90a05922026-06-14WarningsExact identifier
application number: M005
Beilloso Balanitis ReliefMICONAZOLE NITRATE 2% BALANITIS RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4a71c26f-dee5-7b7f-e063-6294a90afcc12026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4c55fcad-c59f-9a6e-e063-6394a90a6c5f2026-06-14WarningsExact identifier
application number: M005
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENTKLIPP EXTRA STRENGTH TOENAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd54430f20-72db-64f7-e063-6394a90a2cc32026-06-14WarningsExact identifier
application number: M005
Bldaxn FUNGAL NAIL RENEWZLUNDECYLENIC ACID 25% FUNGAL NAIL RENEWZLJiangxi Yudexi Pharmaceutical Co., LTD4993181e-68d5-6b91-e063-6294a90a65ce2026-06-12WarningsExact identifier
application number: M005
NATUHEAL MULTI -PURPOSE TREATMENTTOLNAFTATE 1% MULTI -PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a469862-85ab-4c24-e063-6294a90ad2452026-06-12WarningsExact identifier
application number: M005
cmojsk TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOLNAFTATE 1% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD524bbb36-df7b-f21a-e063-6394a90ad0f12026-06-12WarningsExact identifier
application number: M005
BODYKOO NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD535191e9-dc55-0c60-e063-6394a90a330f2026-06-12WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5214a267-0bab-59b8-e063-6394a90adb842026-06-12WarningsExact identifier
application number: M005
EVERFERE ANTIFUNGALUNDECYLENIC ACID 10% ZINC UNDECYLENATE 12% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4bc99af7-ea08-8543-e063-6294a90a44cd2026-06-12WarningsExact identifier
application number: M005
nail fungus treatmentTOLNAFTATEGuangzhou Liyan Cosmetics Technology Co., Ltd.54ee5e53-8c99-01f8-e063-6394a90ae3822026-06-12WarningsExact identifier
application number: M005
Kopa Haiku Antifungal Soap.TOLNAFTATE 1%Trovina Co. Ltd514fc45c-aadb-6205-e063-6394a90ae4732026-06-11WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP53fed66b-a371-38d2-e063-6294a90a510e2026-06-11WarningsExact identifier
application number: M005
SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASHSEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASHGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd54050e6b-a7f1-5067-e063-6394a90aebe52026-06-11WarningsExact identifier
application number: M005
Velloryn 1% Clotrimazole ANTIFUNGALVELLORYN 1% CLOTRIMAZOLE ANTIFUNGALGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd540652da-f8f0-01ee-e063-6294a90a12e92026-06-11WarningsExact identifier
application number: M005
Fitcube NAIL REPAIR PENUNDECYLENIC ACID 25% TOLNAFTATE 1% NAIL REPAIR PENJiangxi Yudexi Pharmaceutical Co., LTD5365268e-7845-4a91-e063-6294a90ac6bf2026-06-10WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEWalgreens Company3858402f-783b-9292-e063-6294a90abe382026-06-10WarningsExact identifier
application number: M005
Hermon Antifungal cleansing barTOLNAFTATE 1%Beautivity LLC53cd1a2b-6ca6-c93b-e063-6394a90aaf3a2026-06-09WarningsExact identifier
application number: M005
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMTwincraft Inc.29698d9e-8449-ceee-e063-6394a90a366e2026-06-09WarningsExact identifier
application number: M005
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMDefense Soap LLC040264b2-8f2f-f059-e063-6294a90ad7202026-06-09WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83691-003-0183691000301453 g in 1 POUCH (83691-003-01) 453 g2025-03-28NoNoCurrent
83691-003-02836910003022 POUCH in 1 BAG (83691-003-02) / 453 g in 1 POUCH2 pouch2025-03-28NoNoCurrent
83691-003-03836910003034 POUCH in 1 BAG (83691-003-03) / 453 g in 1 POUCH4 pouch2025-03-28NoNoCurrent