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United States · US · US:51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa

Jock Itch

Orange BookUNIISPLATC D01AE23

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD01AE23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5167221011
    1 TUBE in 1 CARTON (51672-2101-1) / 15 g in 1 TUBE
  • ndc11
    5167221012
    1 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE
  • ndc11
    5167221018
    1 TUBE in 1 CARTON (51672-2101-8) / 12 g in 1 TUBE
  • ndc11
    5167221019
    1 TUBE in 1 CARTON (51672-2101-9) / 24 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
R8XA2029ZI
BUTENAFINE HYDROCHLORIDE
RxCUI 236558
Orange Book
A205181
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R8XA2029ZI",
    "rxcui": "236558",
    "inchikey": "LJBSAUIFGPSHCN-UHFFFAOYSA-N",
    "display_name": "BUTENAFINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "bb9e3e35-abd8-4f7b-a8e3-90218940fd6b": {
      "match": "brand_token",
      "title": "JOCK ITCH MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [RIDA LLC]",
      "spl_version": "1",
      "published_date": "2026-04-22"
    }
  },
  "productid": "51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa",
  "productndc": "51672-2101",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "205181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Nov 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BUTENAFINE HYDROCHLORIDE",
  "proprietary_name": "Jock Itch",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA205181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butenafine Hydrochloride",
  "start_marketing_date": "20171117",
  "active_numerator_strength": "10"
}

Related drugs

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