Duratuss AC

UNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPoly Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5099154016
473 mL in 1 BOTTLE (50991-540-16)
ndc11
5099154020
20 mL in 1 BOTTLE (50991-540-20)

Annotations

UNII (FDA Substance ID)

GSL05Y1MN6

CODEINE PHOSPHATE

RxCUI 2672

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "GSL05Y1MN6",
    "rxcui": "2672",
    "inchikey": "DKSZLDSPXIWGFO-BLOJGBSASA-N",
    "display_name": "CODEINE PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3e5ed178-d5d9-b8d4-e063-6394a90a91db": {
      "match": "brand_token",
      "title": "DURATUSS AC (CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE) LIQUID [POLY PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-11-24"
    }
  },
  "productid": "50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db",
  "productndc": "50991-540",
  "dosage_form": "LIQUID",
  "dea_schedule": "CV",
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE",
  "proprietary_name": "Duratuss AC",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Codeine Phosphate, Dexbrompheniramine Maleate",
  "start_marketing_date": "20250908",
  "active_numerator_strength": "10; 1"
}

Related drugs

Other records sharing ATC code R05DA.

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