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United States · US · US:72854-001_53490589-6b93-42b2-e063-6394a90a3c02

Mucinex

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerReckitt Benckiser LLC
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7285400116
    2 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    7285400132
    4 BLISTER PACK in 1 CARTON (72854-001-32) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    7285400150
    5 BLISTER PACK in 1 CARTON (72854-001-50) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
N217338
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": "72854-001_53490589-6b93-42b2-e063-6394a90a3c02",
  "productndc": "72854-001",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217338",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG;600MG;110MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM",
  "proprietary_name": "Mucinex",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA217338",
  "marketing_category": "NDA",
  "nonproprietary_name": "Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin",
  "start_marketing_date": "20260601",
  "active_numerator_strength": "30; 600; 110"
}

Related drugs

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