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United States · US · US:35916-0760_47b53021-eb30-c736-e063-6294a90ae369

Dextromethorphan Hbr,Guaifenesin

UNIISPLATC R05DA

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

Identification

ManufacturerSOFTGEL HEALTHCARE PRIVATE LIMITED
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3591607601
    1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0760-1)

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4fde00af-3824-44f1-8a5f-d88518e0a8c8": {
      "match": "brand_token",
      "title": "DEXTROMETHORPHAN POLISTIREX SUSPENSION, EXTENDED RELEASE [AUROHEALTH LLC]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "35916-0760_47b53021-eb30-c736-e063-6294a90ae369",
  "productndc": "35916-0760",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Dextromethorphan Hbr,Guaifenesin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan Hbr,Guaifenesin",
  "start_marketing_date": "20250321",
  "active_numerator_strength": "10; 200"
}

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