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United States · US · US:35916-0461_5003763c-806d-cd6b-e063-6294a90a374f

Dextromethorphan Hydrobromide

UNIISPLATC N07XX59

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

Identification

ManufacturerSoftgel Healthcare Pvt Ltd
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    3591604611
    20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1)
  • ndc11
    3591604612
    1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2)
  • ndc11
    3591604613
    2 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • ndc11
    3591604614
    2 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

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": "35916-0461_5003763c-806d-cd6b-e063-6294a90a374f",
  "productndc": "35916-0461",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "Dextromethorphan Hydrobromide",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan Hydrobromide",
  "start_marketing_date": "20240911",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N07XX59.

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