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 23 of 49 · 973 matching rows.
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