RoyceDerm CoolDefense Refreshing Shower Gel

UNIISPLATC D01AE18

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

Identification

ManufacturerRoyceDerm LLC

CountryUS (United States)

ATC codeD01AE18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8542400701
2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)

06KB629TKV

TOLNAFTATE

RxCUI 10637

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "06KB629TKV",
    "rxcui": "10637",
    "inchikey": "FUSNMLFNXJSCDI-UHFFFAOYSA-N",
    "display_name": "TOLNAFTATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "40089a7d-c893-4e90-e063-6294a90aa6f9": {
      "match": "brand_token",
      "title": "ROYCEDERM TINEA ANTIFUNGAL CREAM (MICONAZOLE NITRATE 2%) CREAM [ROYCEDERM LLC]",
      "spl_version": "2",
      "published_date": "2026-05-07"
    }
  },
  "productid": "85424-007_3b3216d6-8cc9-ea89-e063-6294a90ab691",
  "productndc": "85424-007",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TOLNAFTATE",
  "proprietary_name": "RoyceDerm CoolDefense Refreshing Shower Gel",
  "active_ingred_unit": "g/100mL",
  "application_number": "M005",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Tolnaftate 1.0%",
  "start_marketing_date": "20250831",
  "active_numerator_strength": "1"
}

Related drugs

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