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United States · US · US:68196-999_353ffab0-e812-3948-08ea-c649e60aa08f
Members Mark Mucus Relief DM
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSAM'S WEST INC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168196999564 BLISTER PACK in 1 CARTON (68196-999-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A217340
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": {
"69adad06-48f7-40d5-bca1-ae8e50ab1646": {
"match": "brand_token",
"title": "MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]",
"spl_version": "5",
"published_date": "2026-04-20"
}
},
"productid": "68196-999_353ffab0-e812-3948-08ea-c649e60aa08f",
"productndc": "68196-999",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "217340",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG;600MG",
"product_no": "001",
"approval_date": "Aug 1, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;1.2GM",
"product_no": "002",
"approval_date": "Aug 1, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Members Mark Mucus Relief DM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA217340",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Dextromethorphan HBR",
"start_marketing_date": "20230815",
"active_numerator_strength": "60; 1200"
}Related drugs
Other records sharing ATC code R05DA.
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