🇺🇸
United States · US · US:51862-765_1314d411-e0a5-402b-89ff-49847937838d
Rhofade
Orange BookUNIISPLATC D11AX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma
CountryUS (United States)
ATC codeD11AX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11518627650015 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE
- ndc1151862765301 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
K89MJ0S5VY
OXYMETAZOLINE HYDROCHLORIDE
RxCUI 106101
Orange Book
N208552
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K89MJ0S5VY",
"rxcui": "106101",
"inchikey": "BEEDODBODQVSIM-UHFFFAOYSA-N",
"display_name": "OXYMETAZOLINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"f7dbf12e-a802-4261-bae2-c20977698933": {
"match": "brand_token",
"title": "RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [MAYNE PHARMA]",
"spl_version": "2",
"published_date": "2025-07-09"
}
},
"productid": "51862-765_1314d411-e0a5-402b-89ff-49847937838d",
"productndc": "51862-765",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "208552",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Jan 18, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXYMETAZOLINE HYDROCHLORIDE",
"proprietary_name": "Rhofade",
"active_ingred_unit": "mg/g",
"application_number": "NDA208552",
"marketing_category": "NDA",
"nonproprietary_name": "oxymetazoline hydrochloride",
"start_marketing_date": "20241024",
"active_numerator_strength": "10"
}Related drugs
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