Eurax

Orange BookUNIISPL

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

Identification

ManufacturerJourney Medical Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6948931160
1 TUBE in 1 CARTON (69489-311-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

D6S4O4XD0H

CROTAMITON

RxCUI 21766

Orange Book

N006927

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": {
    "99c826aa-c7dd-4e60-be9c-e9c151033d13": {
      "match": "brand_token",
      "title": "EURAX (CROTAMITON) CREAM [JOURNEY MEDICAL CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-03-16"
    }
  },
  "productid": "69489-311_4640ba32-cf20-18ad-e063-6394a90a4592",
  "productndc": "69489-311",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "006927",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CROTAMITON",
  "proprietary_name": "Eurax",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA006927",
  "marketing_category": "NDA",
  "nonproprietary_name": "crotamiton",
  "start_marketing_date": "20260316",
  "active_numerator_strength": "100"
}

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