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United States · US · US:37808-384_76f9d0f8-2bb8-4eac-84ea-a8e1ca36d51b

Cough DM

Orange BookUNIISPLATC N07XX59

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3780838421
    1 BOTTLE in 1 CARTON (37808-384-21) / 89 mL in 1 BOTTLE
  • ndc11
    3780838428
    1 BOTTLE in 1 CARTON (37808-384-28) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
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": {
    "ff39084f-ab2f-48ed-ac62-837f7fff2b65": {
      "match": "brand_token",
      "title": "COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]",
      "spl_version": "11",
      "published_date": "2026-06-01"
    }
  },
  "productid": "37808-384_76f9d0f8-2bb8-4eac-84ea-a8e1ca36d51b",
  "productndc": "37808-384",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "091135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG HYDROBROMIDE/5ML",
        "product_no": "001",
        "approval_date": "May 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "Cough DM",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan polistirex",
  "start_marketing_date": "20120830",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N07XX59.

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