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United States · US · US:58593-003_23fb59f8-53e6-1152-e063-6294a90a683c

Rompe Pecho NT

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerEfficient Laboratories Inc
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5859300306
    180 mL in 1 BOTTLE (58593-003-06)

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": {
    "4f86985c-48f3-2148-e063-6394a90ae2f1": {
      "match": "brand_token",
      "title": "ROMPE PECHO MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]",
      "spl_version": "1",
      "published_date": "2026-04-17"
    }
  },
  "productid": "58593-003_23fb59f8-53e6-1152-e063-6294a90a683c",
  "productndc": "58593-003",
  "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": "Rompe Pecho NT",
  "active_ingred_unit": "mg/30mL; mg/30mL; mg/30mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate",
  "start_marketing_date": "20231001",
  "active_numerator_strength": "650; 20; 12.5"
}

Related drugs

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