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United States · US · US:55505-230_3dbd264d-5108-4b29-8881-728cea879dd7

SAFETUSSIN MAX STRENGTH MS

In shortageUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    5550523024
    24 TABLET in 1 CARTON (55505-230-24)

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": {
    "920bde5f-4079-45de-aa59-24b00e50cb56": {
      "match": "brand_token",
      "title": "SAFETUSSIN MAX STRENGTH MS COUGH, COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) TABLET [KRAMER LABORATORIES]",
      "spl_version": "2",
      "published_date": "2025-12-31"
    }
  },
  "productid": "55505-230_3dbd264d-5108-4b29-8881-728cea879dd7",
  "productndc": "55505-230",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "SAFETUSSIN MAX STRENGTH MS",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin",
  "start_marketing_date": "20240517",
  "active_numerator_strength": "325; 10; 200"
}

Related drugs

Other records sharing ATC code N02BE.

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