United States· US:63824-056_4ef8ad27-7b5d-144c-e063-6294a90a1928

Mucinex DM

A opium alkaloids and derivatives product containing guaifenesin and dextromethorphan hydrobromide, registered in United States by Reckitt Benckiser LLC. The same ATC class is registered in 2 of our 19 countries.

ATC R05DAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMucinex DMATCR05DAREGISTER NO.US:63824-056_4ef8ad27…PACKS LISTED10CHECKEDJune 3, 2026

Where it is registered

Guaifenesin and dextromethorphan hydrobromide is registered in 2 of 19 countries.

Countries holding a registration under ATC R05DA (opium alkaloids and derivatives), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Guaifenesin and dextromethorphan hydrobromide · ATC R05DA

2 / 19 countries

  • Belgiumprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Guaifenesin and Dextromethorphan Hydrobromide
Manufacturer
Reckitt Benckiser LLC
Country
United States (US)
ATC code
R05DA
ATC class
Opium alkaloids and derivatives
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 10

  • ndc11
    6382405601
    5 BLISTER PACK in 1 CARTON (63824-056-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405632
    1 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405634
    2 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405636
    1 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405650
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50)
  • ndc11
    6382405669
    3 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405672
    2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)
  • ndc11
    6382405674
    24 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)
  • ndc11
    6382405680
    2 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6382405689
    4 BLISTER PACK in 1 CARTON (63824-056-89) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
N021620
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/58615bf3-d2fa-4ecd-9683-b61acbc7918e
GET /v1/drugs/58615bf3-d2fa-4ecd-9683-b61acbc7918e?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "63824-056_4ef8ad27-7b5d-144c-e063-6294a90a1928",
  "productndc": "63824-056",
  "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"
}

See everything about guaifenesin and dextromethorphan hydrobromide.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.