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United States · US · US:50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1

DELSYM

Orange BookUNIISPLATC N07XX59

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009002240
    1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7355X3ROTS
DEXTROMETHORPHAN
RxCUI 236146
Orange Book
N018658
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7355X3ROTS",
    "rxcui": "236146",
    "inchikey": "MKXZASYAUGDDCJ-NJAFHUGGSA-N",
    "display_name": "DEXTROMETHORPHAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a43d59f9-3a6c-4a7c-b98d-b86d6035f716": {
      "match": "brand_token",
      "title": "DELSYM COUGH (DEXTROMETHORPHAN HYDROBROMIDE) TABLET [RECKITT BENCKISER LLC]",
      "spl_version": "5",
      "published_date": "2026-05-29"
    }
  },
  "productid": "50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1",
  "productndc": "50090-0224",
  "dosage_form": "SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "018658",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG HYDROBROMIDE/5ML",
        "product_no": "001",
        "approval_date": "Oct 8, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN",
  "proprietary_name": "DELSYM",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA018658",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextromethorphan",
  "start_marketing_date": "20100504",
  "active_numerator_strength": "30"
}

Related drugs

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