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United States · US · US:55758-384_487431f0-067c-126f-e063-6394a90a0371

SanaTos

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
    5575838406
    6 GRANULE, FOR SOLUTION in 1 CARTON (55758-384-06)

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": "55758-384_487431f0-067c-126f-e063-6394a90a0371",
  "productndc": "55758-384",
  "dosage_form": "GRANULE, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "SanaTos",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride",
  "start_marketing_date": "20240331",
  "active_numerator_strength": "650; 20; 10"
}

Related drugs

Other records sharing ATC code N02BE.

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