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United States · US · US:0031-0100_43e64251-a916-1cb7-e063-6294a90a393a

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu

In shortageUNIISPLATC N02BE

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

Identification

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

Packs · 0

No packs registered.

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": {
    "868ac65a-63e2-46ac-b87d-66b289086756": {
      "match": "brand_token",
      "title": "ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]",
      "spl_version": "11",
      "published_date": "2026-01-09"
    }
  },
  "productid": "0031-0100_43e64251-a916-1cb7-e063-6294a90a393a",
  "productndc": "0031-0100",
  "dosage_form": "LIQUID",
  "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": "Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu",
  "active_ingred_unit": "mg/20mL; mg/20mL; mg/20mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin",
  "start_marketing_date": "20240215",
  "active_numerator_strength": "650; 20; 400"
}

Related drugs

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