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United States · US · US:53942-516_b505e146-c5c6-4f36-8cbb-cb08c0940bcc

Cold, Flu and Sore Throat

In shortageUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDeMoulas Market Basket
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5394251625
    177 mL in 1 BOTTLE (53942-516-25)

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": {
    "3666cf90-54f8-4bd0-a1de-f77c97f1c045": {
      "match": "brand_token",
      "title": "COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]",
      "spl_version": "4",
      "published_date": "2026-04-23"
    }
  },
  "productid": "53942-516_b505e146-c5c6-4f36-8cbb-cb08c0940bcc",
  "productndc": "53942-516",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Cold, Flu and Sore Throat",
  "active_ingred_unit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20130919",
  "active_numerator_strength": "650; 20; 400; 10"
}

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