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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
- ndc1172854001162 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1172854001324 BLISTER PACK in 1 CARTON (72854-001-32) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1172854001505 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
Other records sharing ATC code R05DA.
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