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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

  • ndc11
    3591601881
    1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1)
  • ndc11
    3591601882
    2 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • ndc11
    3591601883
    2 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • ndc11
    3591601884
    2 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

Other records sharing ATC code N02BE.

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