Mucinex DM

Orange BookUNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009065490
24 BLISTER PACK in 1 CARTON (50090-6549-0) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "50090-6549_86b06691-64db-44e1-95d9-bede805160a4",
  "productndc": "50090-6549",
  "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": "60; 1200"
}

Related drugs

Other records sharing ATC code R05DA.

Access this data programmatically

Query Mucinex DM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs