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United States · US · US:85237-1650_46fd8719-fbcb-afb5-e063-6394a90ade32
Mucinex DM
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSelect Consumer Group
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1185237165012 TABLET, EXTENDED RELEASE in 1 POUCH (85237-1650-1)
- ndc1185237165021 POUCH in 1 BLISTER PACK (85237-1650-2) / 2 TABLET, EXTENDED RELEASE in 1 POUCH
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": "85237-1650_46fd8719-fbcb-afb5-e063-6394a90ade32",
"productndc": "85237-1650",
"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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