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United States · US · US:0299-5945_c8da4970-d262-4f55-a092-0a469789eb1f
TWYNEO
Orange BookUNIISPLATC D10AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD10AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1102995945006 g in 1 TUBE (0299-5945-00)
- ndc11029959450530 g in 1 BOTTLE, PUMP (0299-5945-05)
- ndc1102995945301 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 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": "0299-5945_c8da4970-d262-4f55-a092-0a469789eb1f",
"productndc": "0299-5945",
"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": "tretinoin and benzoyl peroxide",
"start_marketing_date": "20220315",
"active_numerator_strength": "30; 1"
}Related drugs
Other records sharing ATC code D10AD.
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelPenlan Pharmaceuticals Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAltair Science Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelZentiva Pharma UK Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelZydus Pharmaceuticals UK Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAlliance Healthcare (Distribution) Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAristo Pharma Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelColorama Pharmaceuticals Ltd
- GBAdapalene 0.3% / Benzoyl peroxide 2.5% gelZentiva Pharma UK Ltd
Access this data programmatically
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