Assured Calamine

UNIISPL

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

Identification

ManufacturerGreenbriar International

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3399241306
177 mL in 1 BOTTLE, PLASTIC (33992-4130-6)

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": {
    "d9d22e45-1a13-4b45-910d-1183a8e6ed7d": {
      "match": "brand_token",
      "title": "ASSURED HEADACHE PM (ASPIRIN FREE) (ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [SPIRIT PHARMACEUTICAL LLC]",
      "spl_version": "6",
      "published_date": "2025-01-01"
    }
  },
  "productid": "33992-4130_0ccb40f9-0734-b059-e063-6394a90aa03c",
  "productndc": "33992-4130",
  "dosage_form": "LOTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ZINC OXIDE",
  "proprietary_name": "Assured Calamine",
  "active_ingred_unit": "mg/mL",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Calamine 8% and Zinc Oxide 8%",
  "start_marketing_date": "20200127",
  "active_numerator_strength": "160"
}

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