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United States · US · US:36800-426_d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3

Topcare Tioconazole 1

Orange BookUNIISPLATC G01AF08

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG01AF08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3680042654
    1 POUCH in 1 CARTON (36800-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
S57Y5X1117
TIOCONAZOLE
RxCUI 38298
Orange Book
A075915
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S57Y5X1117",
    "rxcui": "38298",
    "inchikey": "QXHHHPZILQDDPS-UHFFFAOYSA-N",
    "display_name": "TIOCONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-426_d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3",
  "productndc": "36800-426",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "075915",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6.5%",
        "product_no": "001",
        "approval_date": "Nov 21, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TIOCONAZOLE",
  "proprietary_name": "Topcare Tioconazole 1",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA075915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tioconazole",
  "start_marketing_date": "20080303",
  "active_numerator_strength": "6.5"
}

Related drugs

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