🇺🇸
United States · US · US:68163-540_3fc2f39e-6e41-a802-e063-6394a90a1cc5
severe cold and cough
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRARITAN PHARMACEUTICALS INC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168163540066 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06)
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": "68163-540_3fc2f39e-6e41-a802-e063-6394a90a1cc5",
"productndc": "68163-540",
"dosage_form": "POWDER, FOR SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "severe cold and cough",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"start_marketing_date": "20190314",
"active_numerator_strength": "650; 20; 10"
}Related drugs
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