DOCOSANOL

Orange BookUNIISPLATC D06BB11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCosette Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeD06BB11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0713035302
1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE
ndc11
0713035362
1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)

9G1OE216XY

DOCOSANOL

RxCUI 594680

Orange Book

A215839

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": "0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4",
  "productndc": "0713-0353",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "215839",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10%",
        "product_no": "001",
        "approval_date": "May 3, 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": "ANDA215839",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docosanol",
  "start_marketing_date": "20240104",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code D06BB11.

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