AZZURX

UNIISPL

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

Identification

ManufacturerOutbreaks, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8324300101
3 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)

P0M7O4Y7YD

CALENDULA OFFICINALIS FLOWER

RxCUI 1309289

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P0M7O4Y7YD",
    "rxcui": "1309289",
    "inchikey": null,
    "display_name": "CALENDULA OFFICINALIS FLOWER",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "9e48aaac-48c2-451d-9f6f-369e65c1c52b": {
      "match": "brand_token",
      "title": "AZZURX (MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALLS) LIQUID [OUTBREAKS, INC.]",
      "spl_version": "3",
      "published_date": "2025-01-16"
    }
  },
  "productid": "83243-001_29f05aaf-89b2-e293-e063-6394a90ad0e5",
  "productndc": "83243-001",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CALENDULA OFFICINALIS FLOWER; GERANIUM MACULATUM ROOT; MELISSA OFFICINALIS LEAF; THUJA OCCIDENTALIS LEAF",
  "proprietary_name": "AZZURX",
  "active_ingred_unit": "[hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED HOMEOPATHIC",
  "nonproprietary_name": "MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS",
  "start_marketing_date": "20230213",
  "active_numerator_strength": "3; 3; 3; 3"
}

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