Over-the-counter drug · OTC MONOGRAPH DRUG
ERWCNMIE Toenail Fungus Treatment Pen (Tolnaftate, undecylenic acid) NDC 83766-108
Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL · Liquid · Topical · Shenzhen Joyuflsh Technology Co.,Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83766-108-01 | 8376601080183766010801 | 3 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-01) / 5 mL in 1 BOTTLE, WITH APPLICATORMarketed from Sep 2, 2025 | |
| 83766-108-02 | 8376601080283766010802 | 6 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-02) / 5 mL in 1 BOTTLE, WITH APPLICATORMarketed from Sep 2, 2025 | |
| 83766-108-03 | 8376601080383766010803 | 9 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-03) / 5 mL in 1 BOTTLE, WITH APPLICATORMarketed from Sep 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ERWCNMIE Toenail Fungus Treatment Pen
- Generic name (nonproprietary)
- tolnaftate, undecylenic acid
- Active ingredients
- Tolnaftate — 1 g/100mLUndecylenic acid — 25 g/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Shenzhen Joyuflsh Technology Co.,Ltd.NDC labeler code 83766
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 83766-108_3dce0c33-d4f4-5135-e063-6394a90a85a6SPL ID 3dce0c33-d4f4-5135-e063-6394a90a85a6SPL set ID 3dce0c33-d4f3-5135-e063-6394a90a85a6RxCUI 2691548UNII 06KB629TKV, K3D86KJ24N
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483766010801followed by a unit qualifier and the quantityPackage 83766-0108-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
For the effective treatment of nail fungus-including discoloration,. thickening, splitting, crumbling, and brittleness.
Excerpt only. Read the full label for complete information.
About NDC 83766-108
- What is NDC 83766-108?
- 83766-108 is the product NDC for ERWCNMIE Toenail Fungus Treatment Pen, Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL liquid, listed with the FDA by Shenzhen Joyuflsh Technology Co.,Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ERWCNMIE Toenail Fungus Treatment Pen (Tolnaftate, UNDECYLENIC ACID).
- What is the active ingredient?
- Tolnaftate, Undecylenic acid.
- Who is the labeler?
- Shenzhen Joyuflsh Technology Co.,Ltd., NDC labeler code 83766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ERWCNMIE Toenail Fungus Treatment Pen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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