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United States · US · US:84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03

SUDOCREM SKIN PROTECTANT

UNIISPL

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

Identification

ManufacturerLEDA INNOVATIONS USA, INC.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    8458900210
    1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR
  • ndc11
    8458900212
    125 g in 1 JAR (84589-002-12)
  • ndc11
    8458900225
    250 g in 1 JAR (84589-002-25)
  • ndc11
    8458900240
    400 g in 1 JAR (84589-002-40)
  • ndc11
    8458900260
    60 g in 1 JAR (84589-002-60)

Annotations

UNII (FDA Substance ID)
SOI2LOH54Z
ZINC OXIDE
RxCUI 11423
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SOI2LOH54Z",
    "rxcui": "11423",
    "inchikey": "RNWHGQJWIACOKP-UHFFFAOYSA-N",
    "display_name": "ZINC OXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "20d2cf0b-d237-fd78-e063-6394a90a8d03": {
      "match": "brand_token",
      "title": "SUDOCREM SKIN PROTECTANT (ZINC OXIDE) CREAM [LEDA INNOVATIONS USA, INC.]",
      "spl_version": "1",
      "published_date": "2024-08-30"
    }
  },
  "productid": "84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03",
  "productndc": "84589-002",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ZINC OXIDE",
  "proprietary_name": "SUDOCREM SKIN PROTECTANT",
  "active_ingred_unit": "mg/g",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ZINC OXIDE",
  "start_marketing_date": "20240806",
  "active_numerator_strength": "152.9"
}

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