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United States · US · US:55758-515_4c26c8bf-0144-ddca-e063-6294a90a3552

Sanatos Nighttime Relief

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerPharmadel LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5575851508
    8 BLISTER PACK in 1 CARTON (55758-515-08) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

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": {
    "3dd3ed85-0c0a-8390-e063-6294a90a668e": {
      "match": "brand_token",
      "title": "SANATOS NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [PHARMADEL LLC]",
      "spl_version": "3",
      "published_date": "2026-05-06"
    }
  },
  "productid": "55758-515_4c26c8bf-0144-ddca-e063-6294a90a3552",
  "productndc": "55758-515",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "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": "Sanatos Nighttime Relief",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "325; 20; 12.5"
}

Related drugs

Other records sharing ATC code N02BE.

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