🇺🇸
United States · US · US:50580-369_21e8a73b-cb4a-6770-e063-6294a90a4a53
Tylenol Cold plus Flu plus Cough
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
- ndc115058036901240 mL in 1 BOTTLE (50580-369-01)
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": "50580-369_21e8a73b-cb4a-6770-e063-6294a90a4a53",
"productndc": "50580-369",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Tylenol Cold plus Flu plus Cough",
"active_ingred_unit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride",
"start_marketing_date": "20190617",
"active_numerator_strength": "325; 10; 6.25; 5"
}Related drugs
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