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United States · US · US:55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c

Severe Nighttime Cold and Flu Relief

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerFamily Dollar (FAMILY WELLNESS)
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5531964108
    237 mL in 1 BOTTLE, PLASTIC (55319-641-08)

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": "55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c",
  "productndc": "55319-641",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Severe Nighttime Cold and Flu Relief",
  "active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCI",
  "start_marketing_date": "20240731",
  "active_numerator_strength": "650; 20; 12.5; 10"
}

Related drugs

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