Guaifenesin and Codeine Phosphate

UNIISPLATC R05DA

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

Identification

ManufacturerPAI Holdings, LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0121077504
118 mL in 1 BOTTLE (0121-0775-04)
ndc11
0121077516
473 mL in 1 BOTTLE (0121-0775-16)

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": "0121-0775_2175415b-f07e-50a6-e063-6394a90acabe",
  "productndc": "0121-0775",
  "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": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Guaifenesin and Codeine Phosphate",
  "start_marketing_date": "20061001",
  "active_numerator_strength": "10; 100"
}

Related drugs

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