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United States · US · US:49580-0346_822c9254-9dc0-40fd-9057-2fc60e0bd248

Nighttime Cold and Flu

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerP & L Development, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4958003462
    355 mL in 1 BOTTLE, PLASTIC (49580-0346-2)
  • ndc11
    4958003464
    118 mL in 1 BOTTLE, PLASTIC (49580-0346-4)
  • ndc11
    4958003468
    237 mL in 1 BOTTLE, PLASTIC (49580-0346-8)

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": {
    "2201d5c0-bd51-47a7-9775-916b18573623": {
      "match": "brand_token",
      "title": "NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [PUBLIX SUPER MARKETS INC]",
      "spl_version": "8",
      "published_date": "2026-05-25"
    }
  },
  "productid": "49580-0346_822c9254-9dc0-40fd-9057-2fc60e0bd248",
  "productndc": "49580-0346",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Nighttime Cold and Flu",
  "active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
  "start_marketing_date": "20141130",
  "active_numerator_strength": "650; 30; 12.5"
}

Related drugs

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