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United States · US · US:0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48
ONEXTON
Orange BookUNIISPLATC D10AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD10AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1101873050353.5 g in 1 TUBE (0187-3050-35)
- ndc1101873050501 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
N050819
ABAB
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": {
"697e760a-c206-4565-8f4e-a8085e215827": {
"match": "brand_token",
"title": "ONEXTON (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [BAUSCH HEALTH US, LLC]",
"spl_version": "20",
"published_date": "2025-08-21"
}
},
"productid": "0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48",
"productndc": "0187-3050",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "050819",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2.5%;EQ 1.2% BASE",
"product_no": "001",
"approval_date": "Oct 23, 2008"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3.75%;EQ 1.2% BASE",
"product_no": "002",
"approval_date": "Nov 24, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
"proprietary_name": "ONEXTON",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "NDA050819",
"marketing_category": "NDA",
"nonproprietary_name": "Clindamycin Phosphate and Benzoyl Peroxide",
"start_marketing_date": "20141124",
"active_numerator_strength": "37.5; 10"
}Related drugs
Other records sharing ATC code D10AF.
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