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United States · US · US:85237-1650_46fd8719-fbcb-afb5-e063-6394a90ade32

Mucinex DM

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerSelect Consumer Group
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8523716501
    2 TABLET, EXTENDED RELEASE in 1 POUCH (85237-1650-1)
  • ndc11
    8523716502
    1 POUCH in 1 BLISTER PACK (85237-1650-2) / 2 TABLET, EXTENDED RELEASE in 1 POUCH

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
N021620
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": {
    "49f1f415-8017-0974-e063-6294a90a8918": {
      "match": "brand_token",
      "title": "MUCINEX 12HR COLD AND FEVER MULTI-SYMPTOM (NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "85237-1650_46fd8719-fbcb-afb5-e063-6394a90ade32",
  "productndc": "85237-1650",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021620",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "001",
        "approval_date": "Apr 29, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "002",
        "approval_date": "Apr 29, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Mucinex DM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021620",
  "marketing_category": "NDA",
  "nonproprietary_name": "Guaifenesin and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20120626",
  "active_numerator_strength": "30; 600"
}

Related drugs

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