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United States · US · US:51862-772_a27367f0-2505-460d-98a1-20fe24f41657

Epsolay

Orange BookUNIISPLATC D10AE01

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

Identification

ManufacturerMayne Pharma Commercial LLC
CountryUS (United States)
ATC codeD10AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5186277230
    1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
N214510
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W9WZN9A0GM",
    "rxcui": "1418",
    "inchikey": "OMPJBNCRMGITSC-UHFFFAOYSA-N",
    "display_name": "BENZOYL PEROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "641981e6-460b-44dd-8146-306c47e5367c": {
      "match": "brand_token",
      "title": "EPSOLAY (BENZOYL PEROXIDE) CREAM [MAYNE PHARMA COMMERCIAL LLC]",
      "spl_version": "2",
      "published_date": "2025-08-14"
    }
  },
  "productid": "51862-772_a27367f0-2505-460d-98a1-20fe24f41657",
  "productndc": "51862-772",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "214510",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Apr 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE",
  "proprietary_name": "Epsolay",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA214510",
  "marketing_category": "NDA",
  "nonproprietary_name": "Benzoyl Peroxide",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "30"
}

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