Signature Care Miconazole 1

Orange BookSPL

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

Identification

ManufacturerSafeway

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2113004000
1 KIT in 1 CARTON (21130-040-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE

Annotations

Orange Book

A079114

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "4f555b8f-5193-e685-e063-6294a90a7ba2": {
      "match": "brand_token",
      "title": "SIGNATURE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]",
      "spl_version": "1",
      "published_date": "2026-04-14"
    }
  },
  "productid": "21130-040_44d0726a-3148-445d-adf6-9dc6204fa0db",
  "productndc": "21130-040",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "079114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%,1.2GM",
        "product_no": "001",
        "approval_date": "Jun 2, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Signature Care Miconazole 1",
  "active_ingred_unit": null,
  "application_number": "ANDA079114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20150928",
  "active_numerator_strength": null
}

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