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United States · US · US:63824-057_52d12ac7-93cd-3f6b-e063-6294a90aaa02
Mucinex D
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerReckitt Benckiser LLC
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163824057181 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1163824057364 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021585
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"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": "63824-057_52d12ac7-93cd-3f6b-e063-6294a90aaa02",
"productndc": "63824-057",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021585",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Jun 22, 2004"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Jun 22, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Mucinex D",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021585",
"marketing_category": "NDA",
"nonproprietary_name": "Guaifenesin and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20120626",
"active_numerator_strength": "600; 60"
}Related drugs
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