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.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
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
- ndc1163824056015 BLISTER PACK in 1 CARTON (63824-056-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824056321 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824056342 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824056361 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc116382405650500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50)
- ndc1163824056693 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824056722 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)
- ndc11638240567424 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)
- ndc1163824056802 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824056894 BLISTER PACK in 1 CARTON (63824-056-89) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Regulatory notes
Same class
Other records under R05DA
Opium alkaloids and derivatives, as other registers publish it.
- BelgiumCodeinesiroop met Eucalyptolsmaak Conforma 2.67 mg/mlConforma
- BelgiumCodeinesiroop met Eucalyptolsmaak Conforma 2.67 mg/mlConforma
- United StatesColdCVS PHARMACY
- United StatesGUAIFENESIN DMCardinal Health 107, LLC
- United StatesMucus Relief DMARMY AND AIR FORCE EXCHANGE SERVICE
- United StatesMucus Relief DM CoughCardinal Health 110, LLC. DBA Leader
- United Statesmucus relief DM MAXRite Aid Corporation
- BelgiumSirupus Codeini Conforma 2.62 mg/mlConforma
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.