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United States · US · US:11344-063_4cd60a24-bce7-f425-e063-6294a90a628b

Calamine

UNIISPL

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

Identification

ManufacturerNice-Pak Products, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1134406330
    177 mL in 1 BOTTLE, PLASTIC (11344-063-30)

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": {
    "61929c97-bd6b-0d7c-e053-2991aa0aa571": {
      "match": "brand_token",
      "title": "CALAMINE (CALAMINE AND ZINC OXIDE) LOTION [WAL-MART STORES, INC.]",
      "spl_version": "9",
      "published_date": "2026-05-28"
    }
  },
  "productid": "11344-063_4cd60a24-bce7-f425-e063-6294a90a628b",
  "productndc": "11344-063",
  "dosage_form": "LOTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FERRIC OXIDE RED; ZINC OXIDE",
  "proprietary_name": "Calamine",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Calamine, Zinc oxide",
  "start_marketing_date": "19890715",
  "active_numerator_strength": "80; 80"
}

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