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United States · US · US:11822-9996_3b1ee432-8657-4ef6-9b89-cf0127157e64
Guaifenesin and Dextromethorphan Hydrobromide HBR
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRITE-AID
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1111822999611 BLISTER PACK in 1 CARTON (11822-9996-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1111822999622 BLISTER PACK in 1 CARTON (11822-9996-2) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A214781
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": "11822-9996_3b1ee432-8657-4ef6-9b89-cf0127157e64",
"productndc": "11822-9996",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "214781",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG;600MG",
"product_no": "001",
"approval_date": "Jul 1, 2021"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;1.2GM",
"product_no": "002",
"approval_date": "Jul 1, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Guaifenesin and Dextromethorphan Hydrobromide HBR",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214781",
"marketing_category": "ANDA",
"nonproprietary_name": "guaifenesin and dextromethorphan hydrobromide",
"start_marketing_date": "20220628",
"active_numerator_strength": "60; 1200"
}Related drugs
Other records sharing ATC code R05DA.
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