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United States · US · US:0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8

ABREVA

Orange BookUNIISPLATC D06BB11

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeD06BB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0135030001
    1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE
  • ndc11
    0135030002
    2 TUBE in 1 PACKAGE (0135-0300-02) / 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": {
    "c39b38a7-dcdd-4c32-8f35-b565c4d3cec6": {
      "match": "brand_token",
      "title": "ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]",
      "spl_version": "16",
      "published_date": "2024-06-21"
    }
  },
  "productid": "0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8",
  "productndc": "0135-0300",
  "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": "ABREVA",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208754",
  "marketing_category": "ANDA",
  "nonproprietary_name": "docosanol",
  "start_marketing_date": "20220325",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code D06BB11.

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