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United States · US · US:79481-0065_46990e21-8c4c-4bc2-91e8-350aced1ceff

Cold Sore Fever Blister Treatment

Orange BookUNIISPLATC D06BB11

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

Identification

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

Packs · 1

  • ndc11
    7948100657
    2 g in 1 BOTTLE, PUMP (79481-0065-7)

Annotations

UNII (FDA Substance ID)
9G1OE216XY
DOCOSANOL
RxCUI 594680
Orange Book
A212385
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": "79481-0065_46990e21-8c4c-4bc2-91e8-350aced1ceff",
  "productndc": "79481-0065",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "212385",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Oct 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOCOSANOL",
  "proprietary_name": "Cold Sore Fever Blister Treatment",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docosanol",
  "start_marketing_date": "20230707",
  "active_numerator_strength": "100"
}

Related drugs

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