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United States · US · US:10157-2124_75847eb8-3765-4c32-8c4c-f39b22d3aab3

Cold Sore Treatment Docosanol

Orange BookUNIISPLATC D06BB11

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

Identification

ManufacturerBlistex Inc.
CountryUS (United States)
ATC codeD06BB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1015721242
    1 TUBE in 1 BLISTER PACK (10157-2124-2) / 2 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
9G1OE216XY
DOCOSANOL
RxCUI 594680
Orange Book
A217090
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9G1OE216XY",
    "rxcui": "594680",
    "inchikey": "NOPFSRXAKWQILS-UHFFFAOYSA-N",
    "display_name": "DOCOSANOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "adb658c8-db8d-4db6-80c8-e0f2de88a2de": {
      "match": "brand_token",
      "title": "COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALMART INC.]",
      "spl_version": "7",
      "published_date": "2026-05-28"
    }
  },
  "productid": "10157-2124_75847eb8-3765-4c32-8c4c-f39b22d3aab3",
  "productndc": "10157-2124",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "217090",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Mar 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOCOSANOL",
  "proprietary_name": "Cold Sore Treatment Docosanol",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA217090",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOCOSANOL",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "100"
}

Related drugs

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