Home NDC 83691-003 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 Ingredient Strength ZINC UNDECYLENATE 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 388VZ25DUR Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83691-003-01 Tea Tree Oil Foot Soak and Body Soak 453 g in 1 POUCH GRANULE 453 1 83691-003-02 Tea Tree Oil Foot Soak and Body Soak 2 in 1 BAG GRANULE 2 1 83691-003-02 Tea Tree Oil Foot Soak and Body Soak 453 g in 1 POUCH GRANULE 453 1 83691-003-03 Tea Tree Oil Foot Soak and Body Soak 453 g in 1 POUCH GRANULE 453 1 83691-003-03 Tea Tree Oil Foot Soak and Body Soak 4 in 1 BAG GRANULE 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83691-003 TEA TREE OIL FOOT SOAK AND BODY SOAK (ZINC UNDECYLENATE) GRANULE [SANSAR, LLC] 1 Current NDC, 5 package rows 20250331_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 41 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 1236-CS Antifungal Powder (Talc Free) 1236-CCANTIFUNGAL POWDER(TALC FREE) Dynarex Corporation 312ba573-4008-83e6-e063-6294a90a4a6d 2025-03-25 Warnings Exact identifier application number: M005 Antifungal Medicated Bar TOLNAFTATE RoyceDerm LLC 31305ed2-a0a0-6d4c-e063-6294a90a6ba5 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antimicrobial Hydrogel Wound Dressing BENZETHONIUM CHLORIDE, THYMOL Lidan, Inc cd5b7a72-1b87-434d-973e-071d2c8a438c 2025-03-25 Warnings Exact identifier application number: M005 Forticept HP Antiseptic Wound Cleanser BENZALKONIUM CHLORIDE, ALLANTOIN Lidan, inc. 41bb46ee-edce-4e1b-bcfd-5c5729e1eb15 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Gel CLOTRIMAZOLE Lidan, Inc. 1b5851fc-ae73-4e54-bb62-3ff928628b97 2025-03-25 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Preferred Pharmaceuticals Inc. 14d2a661-a490-41ca-b84f-f2be3bc271b4 2025-03-24 Warnings Exact identifier application number: M005 Dermatin Antifungal CLOTRIMAZOLE Melaleuca, Inc. e993fa3b-1d85-46b7-bda5-ed875be74c4e 2025-03-20 Warnings Exact identifier application number: M005 1% ketoconazole KETOCONAZOLE TAGRID LLC 30b75584-3a1e-c125-e063-6294a90acaa7 2025-03-19 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Cream CLOTRIMAZOLE Lidan, Inc. 17abeb4d-b211-4b8c-a9d2-4c7baba2450c 2025-03-07 Warnings Exact identifier application number: M005 Terramed Just Think Comfort Antifungal Medicated Body Wipes TOLNAFTATE Rida LLC 34577389-8e5d-49ab-a208-9c87b6f3cec4 2025-03-06 Warnings Exact identifier application number: M005 Athletes Foot MICONAZOLE NITRATE Rida LLC 85e98ef8-75c3-4be1-b59f-40b5312e2137 2025-03-06 Warnings Exact identifier application number: M005 SOUTH BEACH MULTI-PURPOSE NAIL REPAIR UNDECYLENIC ACID SOUTH BEACH HAIR CARE PROFESIONAL INC 2fb0110c-b275-2a17-e063-6394a90a2d30 2025-03-06 Warnings Exact identifier application number: M005 DG Health Athletes Foot CLOTRIMAZOLE Dolgencorp, Inc. 20370b32-21ad-4362-9b46-c6149c907231 2025-02-28 Warnings Exact identifier application number: M005 Family Wellness Clotrimazole 1 Anti Fungal Cream CLOTRIMAZOLE Family Dollar Stores, Inc 0667dd81-5633-494e-857e-45fa276fe72c 2025-02-25 Warnings Exact identifier application number: M005 Family Wellness Athletes Foot Tolnaftate 1 Cream TOLNAFTATE Family Dollar Stores, Inc f72b5bcd-8834-4da9-aa74-78992ec2838f 2025-02-25 Warnings Exact identifier application number: M005 ANTIFUNGAL MEDICATED BODY WASH TOLNAFTATE Rida LLC e3ebce6f-88ca-4100-ac79-d300f44e4891 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX AF TOLNAFTATE The Sisquoc Healthcare Corporation f6cf5315-6678-486c-85b2-d4b3f748600e 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX JOCK ITCH TREATMENT TOLNAFTATE The Sisquoc Healthcare Corporation b2ce1c25-93d5-441f-9b3b-68ae46400c2c 2025-02-25 Warnings Exact identifier application number: M005 Miconazole Nitrate MICONAZOLE NITRATE A-S Medication Solutions bf131f33-3ab2-4f43-add5-920e78ac36a7 2025-02-24 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Preferred Pharmaceuticals Inc. 0052992a-819c-4c55-bd88-201a09a3573a 2025-02-21 Warnings Exact identifier application number: M005
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83691-003-01 83691000301 453 g in 1 POUCH (83691-003-01) 453 g 2025-03-28 No No Current 83691-003-02 83691000302 2 POUCH in 1 BAG (83691-003-02) / 453 g in 1 POUCH 2 pouch 2025-03-28 No No Current 83691-003-03 83691000303 4 POUCH in 1 BAG (83691-003-03) / 453 g in 1 POUCH 4 pouch 2025-03-28 No No Current