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United States · US · US:87512-004_4d6db039-5b98-8f3f-e063-6294a90a9d85

SmileCare Mouth Ulcer Gel

SPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerYantai Aien Biotechnology Co., Ltd.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8751200401
    10 g in 1 TUBE (87512-004-01)
  • ndc11
    8751200402
    15 g in 1 TUBE (87512-004-02)
  • ndc11
    8751200403
    20 g in 1 TUBE (87512-004-03)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "4d6db039-5b97-8f3f-e063-6294a90a9d85": {
      "match": "brand_token",
      "title": "SMILECARE MOUTH ULCER GEL (MENTHOL) GEL [YANTAI AIEN BIOTECHNOLOGY CO., LTD.]",
      "spl_version": "1",
      "published_date": "2026-03-23"
    }
  },
  "productid": "87512-004_4d6db039-5b98-8f3f-e063-6294a90a9d85",
  "productndc": "87512-004",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MENTHOL",
  "proprietary_name": "SmileCare Mouth Ulcer Gel",
  "active_ingred_unit": "g/100g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Menthol",
  "start_marketing_date": "20260320",
  "active_numerator_strength": ".1"
}

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