Back to search
🇺🇸

United States · US · US:58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4

Codeine-Guaifenesin

UNIISPLATC R05DA

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

Identification

ManufacturerMethod Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5865750004
    120 mL in 1 BOTTLE (58657-500-04)
  • ndc11
    5865750016
    473 mL in 1 BOTTLE (58657-500-16)

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": {
    "fe126254-6ee6-48c3-965c-96e4276a5314": {
      "match": "brand_token",
      "title": "CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]",
      "spl_version": "16",
      "published_date": "2026-05-14"
    }
  },
  "productid": "58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4",
  "productndc": "58657-500",
  "dosage_form": "SOLUTION",
  "dea_schedule": "CV",
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CODEINE PHOSPHATE; GUAIFENESIN",
  "proprietary_name": "Codeine-Guaifenesin",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Codeine Phosphate and Guaifenesin",
  "start_marketing_date": "20140401",
  "active_numerator_strength": "10; 100"
}

Related drugs

Other records sharing ATC code R05DA.

Access this data programmatically

Query Codeine-Guaifenesin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.