🇺🇸
United States · US · US:51316-263_fcfcff9e-c6b4-4d99-9c1e-e05349cf2eed
12 HR RELIEF COUGH DM
Orange BookUNIISPLATC N07XX59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeN07XX59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151316263211 BOTTLE in 1 CARTON (51316-263-21) / 89 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
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": {
"d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
"match": "brand_token",
"title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-04-24"
}
},
"productid": "51316-263_fcfcff9e-c6b4-4d99-9c1e-e05349cf2eed",
"productndc": "51316-263",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "091135",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG HYDROBROMIDE/5ML",
"product_no": "001",
"approval_date": "May 25, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"proprietary_name": "12 HR RELIEF COUGH DM",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA091135",
"marketing_category": "ANDA",
"nonproprietary_name": "dextromethorphan polistirex",
"start_marketing_date": "20260414",
"active_numerator_strength": "30"
}Related drugs
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