🇺🇸
United States · US · US:37835-412_33d4125b-83ad-18f0-e063-6394a90a679d
MUCUS RELIEF
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBi-Mart
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11378354122828 TABLET, EXTENDED RELEASE in 1 BOTTLE (37835-412-28)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
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": {
"84b5d83d-aea5-42ed-b20c-96d3b389c8c0": {
"match": "brand_token",
"title": "MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RITE AID CORPORATION]",
"spl_version": "3",
"published_date": "2026-05-28"
}
},
"productid": "37835-412_33d4125b-83ad-18f0-e063-6394a90a679d",
"productndc": "37835-412",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213420",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "May 8, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "May 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "MUCUS RELIEF",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213420",
"marketing_category": "ANDA",
"nonproprietary_name": "GUAIFENESIN",
"start_marketing_date": "20201218",
"active_numerator_strength": "1200"
}Related drugs
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