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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
- ndc1151862771301 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
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