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United States · US · US:63824-221_52d41355-573e-4124-e063-6394a90aae33

Delsym

In shortageUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    6382422166
    180 mL in 1 BOTTLE (63824-221-66)

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": {
    "a43d59f9-3a6c-4a7c-b98d-b86d6035f716": {
      "match": "brand_token",
      "title": "DELSYM COUGH (DEXTROMETHORPHAN HYDROBROMIDE) TABLET [RECKITT BENCKISER LLC]",
      "spl_version": "5",
      "published_date": "2026-05-29"
    }
  },
  "productid": "63824-221_52d41355-573e-4124-e063-6394a90aae33",
  "productndc": "63824-221",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Delsym",
  "active_ingred_unit": "mg/20mL; mg/20mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20190701",
  "active_numerator_strength": "650; 20"
}

Related drugs

Other records sharing ATC code N02BE.

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