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United States · US · US:63824-171_52d13984-c194-57c2-e063-6294a90a8393

Delsym

Orange BookUNIISPLATC N07XX59

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

Identification

ManufacturerReckitt Benckiser LLC
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6382417122
    2 CARTON in 1 CELLO PACK (63824-171-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
  • ndc11
    6382417163
    1 BOTTLE in 1 CARTON (63824-171-63) / 89 mL in 1 BOTTLE
  • ndc11
    6382417165
    1 BOTTLE in 1 CARTON (63824-171-65) / 148 mL in 1 BOTTLE
  • ndc11
    6382417175
    1 BOTTLE in 1 CARTON (63824-171-75) / 15 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": "63824-171_52d13984-c194-57c2-e063-6294a90a8393",
  "productndc": "63824-171",
  "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

Other records sharing ATC code N07XX59.

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