OMZOK ANTIFUNGAL PEN
- Product NDC
- 83804-007
- 11-digit product format
- 838040007
- Labeler code
- 83804
- Product ID
- 83804-007_38edf699-93b0-e550-e063-6294a90a368c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- UNDECYLENIC ACID 25%
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Shenzhen Shandian Jingling Technology Co., Ltd.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-04
- Substance
- UNDECYLENIC ACID
- Active strength
- 25 g/100mL
- 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
- OMZOK ANTIFUNGAL PEN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 25 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998329 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 38edf699-93af-e550-e063-6294a90a368c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83804-007-01 | OMZOK ANTIFUNGAL PEN | 3 mL in 1 APPLICATOR | LIQUID | 3 | 1 | |
| 83804-007-01 | OMZOK ANTIFUNGAL PEN | 5 in 1 CARTON | LIQUID | 5 | 1 |
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 |
|---|---|---|---|---|---|---|
| Athletes Foot | MICONAZOLE NITRATE | Premier Brands of America Inc | 52d0909a-f404-0af4-e063-6394a90a3d0c | 2026-06-01 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 431483f6-2386-9f5c-e063-6294a90af104 | 2026-06-01 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Walgreens Company | 3f8d45e1-54a2-a658-e063-6294a90a6cbb | 2026-06-01 | Warnings | M005 |
| Remedy Nails | UNDECYLENIC ACID | Adwill Labs Inc | 4e87b76c-c430-466a-bc30-fe1785c7c660 | 2026-06-01 | Warnings | M005 |
| Anytalk Nail Fungus Treatment 15ml (1% Tonailate) | TOLNAFTATE1% | Guangzhou Huixue Biotechnology Co., Ltd. | 52f1f654-fba3-e90e-e063-6394a90a1df4 | 2026-05-29 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal .spray. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 52da8be4-467c-c011-e063-6294a90a166f | 2026-05-28 | Warnings | M005 |
| Terramed Just Think Comfort Jock Itch Antifungal Treatment | MICONAZOLE NITRATE | Rida LLC | 2acb9027-8f20-4b77-9b45-17fe11622c7c | 2026-05-27 | Warnings | M005 |
| Quali Life ANTIFUNGAL TEA TREE | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 52b3b0df-3f62-f9bc-e063-6394a90a52b3 | 2026-05-26 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b51877-e04c-569e-e063-6394a90a2fc9 | 2026-05-26 | Warnings | M005 |
| NAIL EXTRA STRENGTH REPAIR PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6208d-53e4-eaa0-e063-6394a90abe7a | 2026-05-26 | Warnings | M005 |
| Toenail Fungus Pen Preventative | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6766f-948b-2602-e063-6294a90a03cf | 2026-05-26 | Warnings | M005 |
| KDMAN | TOLNAFTATE | Dongguan Youmi Trading Co., Ltd | 52a4e836-2059-a49f-e063-6394a90a6556 | 2026-05-25 | Warnings | M005 |
| PUTRIZEN | UNDECYLENIC ACID, TOLNAFTATE | Guangzhou Lianbiquan Biological Technology co., Ltd | 52a58f24-2a11-4d34-e063-6394a90a2924 | 2026-05-25 | Warnings | M005 |
| Eye CareSpray | EYELID CLEANSING SPRAY | Shenzhen Shierjie Biological Engineering Co., LTD | 52aef5dd-ff33-cace-e063-6294a90a415a | 2026-05-25 | Warnings | M005 |
| Saviland PRO Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 5250003a-8d3a-818b-e063-6294a90aa659 | 2026-05-21 | Warnings | M005 |
| Saviland SSPro X Series Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52506297-44d7-b2a7-e063-6394a90a0a3c | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52512e7e-5e28-4383-e063-6294a90a448a | 2026-05-21 | Warnings | M005 |
| Vrenmol Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52516861-e386-d0cb-e063-6394a90a17d0 | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Toenail Renewal Solution | TOLNAFTATE,UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52519110-a3c9-21da-e063-6294a90abbce | 2026-05-21 | Warnings | M005 |
| Fungal Nail Repair Pen | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 523c32f7-b803-bf79-e063-6394a90aad5a | 2026-05-20 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998329 | undecylenic acid 25 % Topical Solution | PSN | 38edf699-93af-e550-e063-6294a90a368c | 1 |
| 998329 | undecylenic acid 250 MG/ML Topical Solution | SCD | 38edf699-93af-e550-e063-6294a90a368c | 1 |
| 998329 | undecylenic acid 25 % Topical Solution | SY | 38edf699-93af-e550-e063-6294a90a368c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83804-007-01 | 83804000701 | 5 APPLICATOR in 1 CARTON (83804-007-01) / 3 mL in 1 APPLICATOR | 5 applicator | 2025-08-04 | No | No | Current |