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United States· US:85966-005_4b8e2c64-1537-9971-e063-6394a90ae68b

Nail Fungus Treatment Pen

A other antifungals for topical use product containing undecylenic acid, tolnaftate, registered in United States by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD.

ATC D01AEUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNail Fungus Treatment PenATCD01AEREGISTER NO.US:85966-005_4b8e2c64…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
UNDECYLENIC ACID, TOLNAFTATE
Manufacturer
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Country
United States (US)
ATC code
D01AE
ATC class
Other antifungals for topical use
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    8596600501
    3 BOTTLE in 1 BOX (85966-005-01) / 5 mL in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
06KB629TKV
TOLNAFTATE
RxCUI 10637
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/6e099d2f-bf37-4e34-b753-294024465b9c
GET /v1/drugs/6e099d2f-bf37-4e34-b753-294024465b9c?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "06KB629TKV",
    "rxcui": "10637",
    "inchikey": "FUSNMLFNXJSCDI-UHFFFAOYSA-N",
    "display_name": "TOLNAFTATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "52b6208d-53e4-eaa0-e063-6394a90abe7a": {
      "match": "brand_token",
      "title": "NAIL EXTRA STRENGTH REPAIR PEN (UNDECYLENIC ACID) LIQUID [GUANGZHOU MIZI BIOTECHNOLOGY CO., LTD.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "85966-005_4b8e2c64-1537-9971-e063-6394a90ae68b",
  "productndc": "85966-005",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TOLNAFTATE; UNDECYLENIC ACID",
  "proprietary_name": "Nail Fungus Treatment Pen",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "M005",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "UNDECYLENIC ACID, TOLNAFTATE",
  "start_marketing_date": "20250929",
  "active_numerator_strength": "1; 25"
}

See everything about undecylenic acid, tolnaftate.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.