Mucinex DM

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8576617620
1 BLISTER PACK in 1 CARTON (85766-176-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
8576617640
2 BLISTER PACK in 1 CARTON (85766-176-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
8576617660
3 BLISTER PACK in 1 CARTON (85766-176-60) / 20 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": "85766-176_4bc7e1b5-c896-c837-e063-6294a90a475a",
  "productndc": "85766-176",
  "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

Other records sharing ATC code R05DA.

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