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United States · US · US:61269-989_29a71b87-09b6-46e5-955a-86c63a618e48

DOCOSANOL

Orange BookUNIISPLATC D06BB11

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

Identification

ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeD06BB11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6126998937
    1 BOTTLE, PUMP in 1 PACKAGE (61269-989-37) / 2 g in 1 BOTTLE, PUMP

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": {
    "336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b": {
      "match": "brand_token",
      "title": "DOCOSANOL CREAM [CVS PHARMACY, INC.]",
      "spl_version": "5",
      "published_date": "2026-03-16"
    }
  },
  "productid": "61269-989_29a71b87-09b6-46e5-955a-86c63a618e48",
  "productndc": "61269-989",
  "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": "DOCOSANOL",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOCOSANOL",
  "start_marketing_date": "20230718",
  "active_numerator_strength": "100"
}

Related drugs

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