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United States · US · US:35916-0185_50036e03-a441-a430-e063-6394a90a72c7
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
In shortageUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSoftgel Healthcare Private Limited
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1135916018523000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2)
- ndc1135916018532 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
- ndc1135916018542 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
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": "35916-0185_50036e03-a441-a430-e063-6394a90a72c7",
"productndc": "35916-0185",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate",
"start_marketing_date": "20250517",
"active_numerator_strength": "325; 10; 6.25"
}Related drugs
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