🇺🇸
United States · US · US:76281-305_95f58511-c4d4-4a9d-b8be-ba0b464f2e59
XL-3 Xtreme
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAptaPharma Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117628130528354 mL in 1 BOTTLE (76281-305-28)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"03210929-331e-462d-b566-4e1865f52246": {
"match": "brand_token",
"title": "XL-3 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [RNV LLC]",
"spl_version": "3",
"published_date": "2026-01-30"
}
},
"productid": "76281-305_95f58511-c4d4-4a9d-b8be-ba0b464f2e59",
"productndc": "76281-305",
"dosage_form": "LIQUID",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "XL-3 Xtreme",
"active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate",
"start_marketing_date": "20180101",
"active_numerator_strength": "650; 30; 12.5"
}Related drugs
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