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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
- ndc1151862772301 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"
}Related drugs
Other records sharing ATC code D10AE01.
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