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United States · US · US:30142-275_c4662fd4-29ea-4e70-b075-2e7dea938af5
Guaifenesin and Dextromethorphan HBr
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKROGER COMPANY
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1130142275054 BLISTER PACK in 1 CARTON (30142-275-05) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1130142275142 BLISTER PACK in 1 CARTON (30142-275-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A206941
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": {
"9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
"match": "brand_token",
"title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "30142-275_c4662fd4-29ea-4e70-b075-2e7dea938af5",
"productndc": "30142-275",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206941",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG;600MG",
"product_no": "001",
"approval_date": "Mar 17, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;1.2GM",
"product_no": "002",
"approval_date": "Mar 17, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Guaifenesin and Dextromethorphan HBr",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA206941",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Dextromethorphan HBr",
"start_marketing_date": "20240521",
"active_numerator_strength": "60; 1200"
}Related drugs
Other records sharing ATC code R05DA.
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