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United States · US · US:61354-118_348c5e36-13f6-cc86-e063-6394a90a8de8

Powder

UNIISPL

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

Identification

ManufacturerOxygen Development LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6135411802
    1 CUP in 1 CARTON (61354-118-02) / 100 mg in 1 CUP (61354-118-01)

Annotations

UNII (FDA Substance ID)
1K09F3G675
FERRIC OXIDE RED
RxCUI 1310572
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1K09F3G675",
    "rxcui": "1310572",
    "inchikey": "LIKBJVNGSGBSGK-UHFFFAOYSA-N",
    "display_name": "FERRIC OXIDE RED",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "41c0c262-21c3-b8e6-e063-6394a90a7c9c": {
      "match": "brand_token",
      "title": "POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]",
      "spl_version": "4",
      "published_date": "2026-03-18"
    }
  },
  "productid": "61354-118_348c5e36-13f6-cc86-e063-6394a90a8de8",
  "productndc": "61354-118",
  "dosage_form": "POWDER",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FERRIC OXIDE RED; TITANIUM DIOXIDE",
  "proprietary_name": "Powder",
  "active_ingred_unit": "mg/100mg; mg/100mg",
  "application_number": "M020",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Titanium Dioxide",
  "start_marketing_date": "20231027",
  "active_numerator_strength": "1.75; 10"
}

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