🇺🇸
United States · US · US:50580-403_223ac56b-afcd-3055-e063-6394a90a7032
TYLENOL COLD PLUS FLU SEVERE
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115058040308240 mL in 1 BOTTLE, PLASTIC (50580-403-08)
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": {
"1622f694-4d63-4c56-8737-fae31f0ecfb7": {
"match": "brand_token",
"title": "TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC]",
"spl_version": "13",
"published_date": "2026-05-28"
}
},
"productid": "50580-403_223ac56b-afcd-3055-e063-6394a90a7032",
"productndc": "50580-403",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "TYLENOL COLD PLUS FLU SEVERE",
"active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride",
"start_marketing_date": "20100705",
"active_numerator_strength": "650; 20; 400; 10"
}Related drugs
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