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United States · US · US:51316-293_9021b677-f0cb-4b32-ab57-1c79d9471621

severe cold and flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131629340
    355 mL in 1 BOTTLE (51316-293-40)

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": {
    "1efd1778-7ab1-4797-98c5-4637940ee3ec": {
      "match": "brand_token",
      "title": "SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "51316-293_9021b677-f0cb-4b32-ab57-1c79d9471621",
  "productndc": "51316-293",
  "dosage_form": "SOLUTION",
  "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": "severe cold and flu",
  "active_ingred_unit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride",
  "start_marketing_date": "20260114",
  "active_numerator_strength": "325; 10; 200; 5"
}

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