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United States · US · US:67492-104_41eb9348-e861-4ac7-e063-6294a90a96cf

Calmol 4

UNIISPL

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

Identification

ManufacturerResical Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6749210411
    4 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK
  • ndc11
    6749210412
    2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK
  • ndc11
    6749210413
    1 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
512OYT1CRR
COCOA BUTTER
RxCUI 21389
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "512OYT1CRR",
    "rxcui": "21389",
    "inchikey": null,
    "display_name": "COCOA BUTTER",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "5516f800-d3fa-4b90-a3eb-c0bdf3183b9b": {
      "match": "brand_token",
      "title": "CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]",
      "spl_version": "12",
      "published_date": "2025-11-17"
    }
  },
  "productid": "67492-104_41eb9348-e861-4ac7-e063-6294a90a96cf",
  "productndc": "67492-104",
  "dosage_form": "SUPPOSITORY",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "COCOA BUTTER; ZINC OXIDE",
  "proprietary_name": "Calmol 4",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M015",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Zinc Oxide and Cocoa Butter",
  "start_marketing_date": "20060513",
  "active_numerator_strength": "2052; 270"
}

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