🇺🇸
United States · US · US:27854-303_8987ddc4-ae5c-4a2a-85b4-e73e63d195fc
SEDALMEX FORTE
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBelmora LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11278543030140 PACKET in 1 BOX (27854-303-01) / 1 TABLET in 1 PACKET
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": {
"f2edfedf-e06e-4d1b-8c2d-732e08ec113c": {
"match": "brand_token",
"title": "SEDALMEX XL FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [BELMORA LLC]",
"spl_version": "7",
"published_date": "2026-03-23"
}
},
"productid": "27854-303_8987ddc4-ae5c-4a2a-85b4-e73e63d195fc",
"productndc": "27854-303",
"dosage_form": "TABLET",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "SEDALMEX FORTE",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "M013",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Aspirin, Caffeine",
"start_marketing_date": "20240601",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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