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United States · US · US:0113-0426_d8396310-fd7a-46be-b31c-41f0006605f2

good sense tioconazole 1

Orange BookUNIISPLATC G01AF08

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeG01AF08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0113042654
    1 POUCH in 1 CARTON (0113-0426-54) / 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": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0113-0426_d8396310-fd7a-46be-b31c-41f0006605f2",
  "productndc": "0113-0426",
  "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": "good sense tioconazole 1",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA075915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tioconazole",
  "start_marketing_date": "20191022",
  "active_numerator_strength": "6.5"
}

Related drugs

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