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United States · US · US:69729-784_30b942ce-4452-9123-e063-6394a90ae60f

Rompe Tos X Children

In shortageUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    6972978406
    1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC

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": "69729-784_30b942ce-4452-9123-e063-6394a90ae60f",
  "productndc": "69729-784",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Rompe Tos X Children",
  "active_ingred_unit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl",
  "start_marketing_date": "20230918",
  "active_numerator_strength": "250; 13.33; 200; 5"
}

Related drugs

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