🇺🇸
United States · US · US:41163-053_0e2c568e-a59f-42bf-86f3-4dc1cd92dd0f
Severe Cold
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1141163053082 BLISTER PACK in 1 CARTON (41163-053-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK
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": {
"1efd1778-7ab1-4797-98c5-4637940ee3ec": {
"match": "brand_token",
"title": "SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-05-13"
}
},
"productid": "41163-053_0e2c568e-a59f-42bf-86f3-4dc1cd92dd0f",
"productndc": "41163-053",
"dosage_form": "TABLET, FILM COATED",
"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": "Severe Cold",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl",
"start_marketing_date": "20230127",
"active_numerator_strength": "325; 10; 200; 5"
}Related drugs
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