🇺🇸
United States · US · US:53041-616_3e372558-1578-4c25-962a-43af6b54de75
Tussnex FM Cold and Sinus
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGuardian Drug Company
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115304161658177 mL in 1 BOTTLE (53041-616-58)
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": {
"387df403-7803-4031-915e-8de9b103a162": {
"match": "brand_token",
"title": "TUSSNEX FM SEVERE COUGH AND CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]",
"spl_version": "5",
"published_date": "2024-12-23"
}
},
"productid": "53041-616_3e372558-1578-4c25-962a-43af6b54de75",
"productndc": "53041-616",
"dosage_form": "LIQUID",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Tussnex FM Cold and Sinus",
"active_ingred_unit": "mg/20mL; mg/20mL; mg/20mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acteaminophen, Guaifenesin, Phenylephrine HCl",
"start_marketing_date": "20121201",
"active_numerator_strength": "650; 400; 10"
}Related drugs
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