🇺🇸
United States · US · US:68210-5053_474d264f-eafa-e891-e063-6394a90a6f40
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProdose, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168210505312 POUCH in 1 CARTON (68210-5053-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
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": {
"353ef34f-760d-ae92-e063-6294a90a5b4a": {
"match": "brand_token",
"title": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
"spl_version": "5",
"published_date": "2026-04-28"
}
},
"productid": "68210-5053_474d264f-eafa-e891-e063-6394a90a6f40",
"productndc": "68210-5053",
"dosage_form": "CAPSULE, LIQUID FILLED",
"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": "Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride",
"start_marketing_date": "20250729",
"active_numerator_strength": "325; 10; 5"
}Related drugs
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