🇺🇸
United States · US · US:35916-0188_5003542f-a0ff-cd67-e063-6294a90aee97
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
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 · 4
- ndc1135916018811000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1)
- ndc1135916018822 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
- ndc1135916018832 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
- ndc1135916018842 BAG in 1 BOX (35916-0188-4) / 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": {
"44520aa1-b63f-4239-e063-6394a90a5e14": {
"match": "brand_token",
"title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "35916-0188_5003542f-a0ff-cd67-e063-6294a90aee97",
"productndc": "35916-0188",
"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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl",
"start_marketing_date": "20250321",
"active_numerator_strength": "325; 10; 5"
}Related drugs
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