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Tea Tree Oil Foot Soak and Body Soak Zinc Undecylenate 10 g/100g Granule — NDC 83691-0003-03 package photo

Tea Tree Oil Foot Soak and Body Soak Zinc Undecylenate 10 g/100g Granule

by SANSAR, LLC · 4 POUCH in 1 BAG (83691-003-03) / 453 g in 1 POUCH
NDC 83691-0003-03
🏷️ FDA NDC (as labeled) 83691-003-03 billing pads the product segment with a zero
This package
Contains453 g in 1 pouch Pack sizes3 compare ↓
Also comes in: 2 pouches 83691-0003-02 453 g 83691-0003-01
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 83691-003-03
Product NDC 83691-003
11-digit billing NDC 83691000303
UNII 388VZ25DUR
Application # M005
SPL Set ID c43816ac-2228-43ce-ba45-80cf3a7788f2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-28
Route TOPICAL
Dosage form GRANULE
Substance ZINC UNDECYLENATE
Why two NDCs? The FDA registers this code as 83691-003-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83691-0003-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSANSAR, LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code83691
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio13 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter topical granule product marketed under FDA's monograph rules for antifungal foot and body soaks. The active ingredient is zinc undecylenate, a compound typically used to help reduce fungal growth on skin. Zinc undecylenate is commonly found in products intended for topical application to areas affected by fungal conditions. The granules are designed to be dissolved in water for soaking.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII SK47B8698T
    A mineral compound containing magnesium, sulfate, and water molecules. Used in medicines as a laxative agent and sometimes as a filler or anti-caking ingredient to improve powder flow and stability.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII 87GE52P74G
    Sea salt is sodium chloride harvested from seawater. It acts as a flavoring agent and preservative in medications, helping enhance taste and prevent microbial growth.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.

11 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesDead Sea Salt, Epsom Salt, Coconut Oil, Tea Tree Oil, Eucalyptus Oil, Lavender Oil, Peppermint Oil, Rosemary Oil, Spearmint Oil, Chamomile Oil, Sodium Bicarbonate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 pouches 453 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tea Tree Oil Foot Soak and Body Soak 10 g/100gthis 83691-0003-03 SANSAR, 4 pouches — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83691-0003-01 453 g in 1 POUCH (83691-003-01) 2025-03-28 Active
83691-0003-02 2 POUCH in 1 BAG (83691-003-02) / 453 g in 1 POUCH 2025-03-28 Active
83691-0003-03 You're viewing this 4 POUCH in 1 BAG (83691-003-03) / 453 g in 1 POUCH 2025-03-28 Active

Pack size FAQ

What quantity is in NDC 83691-0003-03?
NDC 83691-0003-03 is listed by the FDA — 4 pouch in 1 bag / 453 g in 1 pouch.
What NDC number is used to bill for this package of Tea Tree Oil Foot Soak and Body Soak Zinc Undecylenate 10 g/100g Granule?
Bill NDC 83691-0003-03 — the 11-digit billing format is 83691000303. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83691-003-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83691-0003-03, written without dashes as 83691000303. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83691-0003-03, the first segment (83691) is the labeler code FDA assigned to SANSAR, LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SANSAR, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 2 pouches (83691-0003-02), 453 g (83691-0003-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
SANSAR, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 30 words ▾

Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

⏱️ Dosage and Administration 62 words ▾

Direction Fill a foot basin or a bathtub with warm water and add 1 oz of foot soak for every gallon of water, approximately

1.5Tablespoons. Mix with hand until the salt Dissolves. Soak your feet or body for about 15-20 minutes. Add additional salts for a more stringent or aromatic foot & body bath. If condition persists longer, consult a doctor

⚠️ Warnings 38 words ▾

Warning For External use only Do not apply to wounds or damaged skin If pregnant or breast-feeding, ask a health professional before use. Do not use on children under 2 years of age unless directed by a doctor.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Undecylenate 10%

🧪 Inactive Ingredients 26 words ▾

Inactive Ingredients Dead Sea Salt, Epsom Salt, Coconut Oil, Tea Tree Oil, Eucalyptus Oil, Lavender Oil, Peppermint Oil, Rosemary Oil, Spearmint Oil, Chamomile Oil, Sodium Bicarbonate

🎯 Purpose 2 words ▾

Purpose Anti-Fungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83691-0000-00 · SANSAR, 83691-0004-01 · SANSAR, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.