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United States · US · US:51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6

Twyneo

Orange BookUNIISPLATC D10AD

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

Identification

ManufacturerMayne Pharma Commercial LLC
CountryUS (United States)
ATC codeD10AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5186277130
    1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
N214902
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": {
    "654ae869-5bc0-40b3-a423-dcc3270c05d8": {
      "match": "brand_token",
      "title": "TWYNEO (BENZOYL PEROXIDE AND TRETINOIN) CREAM [MAYNE PHARMA COMMERCIAL LLC]",
      "spl_version": "1",
      "published_date": "2025-08-14"
    }
  },
  "productid": "51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6",
  "productndc": "51862-771",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "214902",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3%;0.1%",
        "product_no": "001",
        "approval_date": "Jul 26, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE; TRETINOIN",
  "proprietary_name": "Twyneo",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA214902",
  "marketing_category": "NDA",
  "nonproprietary_name": "Benzoyl Peroxide and Tretinoin",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "30; 1"
}

Related drugs

Other records sharing ATC code D10AD.

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