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United States · US · US:76162-900_a91e107a-2f8e-4eb3-b1be-e93009f2dba1

Cold Sore Fever Blister Treatment

Orange BookUNIISPLATC D06BB11

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

Identification

ManufacturerTopco Associates
CountryUS (United States)
ATC codeD06BB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7616290007
    1 TUBE in 1 PACKAGE (76162-900-07) / 2 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
9G1OE216XY
DOCOSANOL
RxCUI 594680
Orange Book
A208754
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": "76162-900_a91e107a-2f8e-4eb3-b1be-e93009f2dba1",
  "productndc": "76162-900",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "208754",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Nov 19, 2018"
      }
    ],
    "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": "ANDA208754",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docosanol",
  "start_marketing_date": "20220121",
  "active_numerator_strength": "100"
}

Related drugs

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