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 |
|---|---|
| ZINC UNDECYLENATE | 10 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 388VZ25DUR | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c43816ac-2228-43ce-ba45-80cf3a7788f2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6e3c022f-0786-43f1-8857-edff89d5153f | Product name | 1 | 20260309 |
| efd58652-cb8f-4018-91ca-4b0eb2ff729f | Product name | 7 | 20240226 |
| 2641ccb3-721d-4fbf-9f2f-ca2f18157a62 | Product name | 3 | 20210309 |
| e7e58cd3-cacb-49df-8d34-1ee335614abb | Product name | 1 | 20150609 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FUNGAL NAIL TREATMENT kit .liquid. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c93390-ee07-4f78-e063-6394a90add42 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit .cream. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c9d9fa-09ad-e26a-e063-6394a90a0ed9 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56cb7085-87d8-4273-e063-6394a90ac5df | 2026-07-17 | Warnings | M005 |
| BeamBalm ANTIFUNGAL FOOT CARE | TOLNAFTATE 1% ANTIFUNGAL FOOT CARE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b10492-894c-33e1-e063-6394a90a8c0f | 2026-07-17 | Warnings | M005 |
| Foot Choice-Nail Fungal Pen | UNDECYLENIC ACID | Foot Choice LLC | 4b0036a6-8751-4f44-b6b1-5be57fa92cdc | 2026-07-17 | Warnings | M005 |
| 2% MICONAZOLE NITRATE ANTIFUNGAL Cream | 2% MICONAZOLE NITRATE ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56b54359-db21-b8b4-e063-6394a90a6f8c | 2026-07-16 | Warnings | M005 |
| DRAVYNOR BALANITIS RELIEF Cream | MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b76a52-0743-4fe6-e063-6294a90a98a8 | 2026-07-16 | Warnings | M005 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | 5% BENZOYL PEROXIDE FOLLICULITIS CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56c558fa-303f-fc52-e063-6394a90a72f0 | 2026-07-16 | Warnings | M005 |
| Antifungal Ringworm Treatment Cream | MICONAZOLE NITRATE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 56a2ceea-c4c0-c30c-e063-6394a90a0e6a | 2026-07-15 | Warnings | M005 |
| Medi-First Antifungal Cream Miconazole Cream | MICONAZOLE | Unifirst First Aid Corporation | 56a51b75-9c23-bcd2-e063-6394a90a9b12 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Tinea Treatment | CLEAR ROOT LABS TINEA TREATMENT | Aidance Scientic Inc., DBA Aidance Skincare & Topicals | 56a67bad-c677-d3b7-e063-6394a90ad205 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Antifungal Treatment | CLEAR ROOT LABS ANTIFUNGAL TREATMENT | Aidance Scientific, Inc., DBA Aidance Skincare & Topicals | 5696bf23-230a-5f37-e063-6294a90a7413 | 2026-07-15 | Warnings | M005 |
| BeamBalm ANTIFUNGAL NAIL Liquid | TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID | Jiangxi Yudexi Pharmaceutical Co., LTD | 56b17e50-bff1-5eb0-e063-6294a90a3c08 | 2026-07-15 | Warnings | M005 |
| terrasil Antifungal Cleansing Bar | CLOTRIMAZOLE | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 10a4fde0-87e1-4474-bcb5-255b0a7f1ecb | 2026-07-14 | Warnings | M005 |
| OAKDOLCHE Tea Tree Oil Antifungal | TOLNAFTATE | Nanjing Qiaotun Technology Co., Ltd. | 569dee15-e68d-220e-e063-6294a90af7c5 | 2026-07-14 | Warnings | M005 |
| Kimtara Nail Fungus Treatment | KIMTARA NAIL FUNGUS TREATMENT | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 5678e260-10c4-f203-e063-6294a90a6223 | 2026-07-13 | Warnings | M005 |
| Aiilo NAIL FUNGUS TREATMENT | UNDECYLENIC ACID 25% | Guangzhou Huixue Biotechnology Co., Ltd. | 5689ac31-4d23-0fcc-e063-6394a90ac75b | 2026-07-13 | M005 | |
| MIWIFY ANTIFUNGAL NAIL REPAIR PEN | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56519b25-f3c8-bcac-e063-6394a90af879 | 2026-07-11 | Warnings | M005 |
| Joymeey FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5652a22e-7b43-3c31-e063-6294a90ae4f1 | 2026-07-11 | Warnings | M005 |
| iBeaLee Nail Repair Pen | IBEALEE NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 564dc711-7fe2-7a8d-e063-6294a90aac26 | 2026-07-10 | Warnings | M005 |
Packages#
| 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 |