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United States · US · US:70000-0656_8eaad384-c7af-4263-b948-8623a7c06bcb
12 Hour Nasal Decongestant
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCARDINAL HEALTH
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000065611 BLISTER PACK in 1 CARTON (70000-0656-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A077442
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6V9V2RYJ8N",
"rxcui": "91168",
"inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
"display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"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": "70000-0656_8eaad384-c7af-4263-b948-8623a7c06bcb",
"productndc": "70000-0656",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077442",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Sep 28, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "12 Hour Nasal Decongestant",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077442",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine hydrochloride",
"start_marketing_date": "20240516",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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