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United States · US · US:0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8
ABREVA
Orange BookUNIISPLATC D06BB11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeD06BB11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1101350300011 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE
- ndc1101350300022 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
9G1OE216XY
DOCOSANOL
RxCUI 594680
Orange Book
A208754
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9G1OE216XY",
"rxcui": "594680",
"inchikey": "NOPFSRXAKWQILS-UHFFFAOYSA-N",
"display_name": "DOCOSANOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"c39b38a7-dcdd-4c32-8f35-b565c4d3cec6": {
"match": "brand_token",
"title": "ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]",
"spl_version": "16",
"published_date": "2024-06-21"
}
},
"productid": "0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8",
"productndc": "0135-0300",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "208754",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10%",
"product_no": "001",
"approval_date": "Nov 19, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DOCOSANOL",
"proprietary_name": "ABREVA",
"active_ingred_unit": "mg/g",
"application_number": "ANDA208754",
"marketing_category": "ANDA",
"nonproprietary_name": "docosanol",
"start_marketing_date": "20220325",
"active_numerator_strength": "100"
}Related drugs
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