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United States · US · US:68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336

Guaifenesin and Codeine Phosphate

UNIISPLATC R05DA

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878883611
    118 mL in 1 BOTTLE (68788-8361-1)

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": {
    "9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
      "match": "brand_token",
      "title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
      "spl_version": "8",
      "published_date": "2026-05-21"
    }
  },
  "productid": "68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336",
  "productndc": "68788-8361",
  "dosage_form": "SOLUTION",
  "dea_schedule": "CV",
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CODEINE PHOSPHATE; GUAIFENESIN",
  "proprietary_name": "Guaifenesin and Codeine Phosphate",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "MO12",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin and Codeine Phosphate",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "10; 100"
}

Related drugs

Other records sharing ATC code R05DA.

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