Pruradik

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTrifluent Pharma, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7335205110
237 g in 1 BOTTLE, PLASTIC (73352-051-10)

Annotations

UNII (FDA Substance ID)

D6S4O4XD0H

CROTAMITON

RxCUI 21766

Orange Book

A087204

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "D6S4O4XD0H",
    "rxcui": "21766",
    "inchikey": null,
    "display_name": "CROTAMITON",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "3699175f-bfc8-a047-e063-6394a90a80d1": {
      "match": "brand_token",
      "title": "PRURADIK (CROTAMITON) LOTION [TRIFLUENT PHARMA, LLC]",
      "spl_version": "1",
      "published_date": "2025-06-04"
    }
  },
  "productid": "73352-051_36991086-14b5-9e66-e063-6394a90ad654",
  "productndc": "73352-051",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "087204",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CROTAMITON",
  "proprietary_name": "Pruradik",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA087204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Crotamiton",
  "start_marketing_date": "20250602",
  "active_numerator_strength": "100"
}

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