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United States · US · US:80513-371_2f0e58dc-121b-d508-e063-6294a90a34ff
Night Time Sleep Aid
In shortageOrange BookUNIISPLATC R06AA59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx LLC
CountryUS (United States)
ATC codeR06AA59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118051337125225 TABLET in 1 BOTTLE (80513-371-25)
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040564
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release
Raw payload (JSON)
{
"unii": {
"unii": "V9BI9B5YI2",
"rxcui": "23665",
"inchikey": "KBAUFVUYFNWQFM-UHFFFAOYSA-N",
"display_name": "DOXYLAMINE SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"13492631-d5de-4562-a201-664f7d3591de": {
"match": "brand_token",
"title": "NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [CVS PHARMACY]",
"spl_version": "7",
"published_date": "2026-05-28"
}
},
"productid": "80513-371_2f0e58dc-121b-d508-e063-6294a90a34ff",
"productndc": "80513-371",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040564",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 27, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DOXYLAMINE SUCCINATE",
"shortage_reason": "Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release",
"shortage_status": "current",
"proprietary_name": "Night Time Sleep Aid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040564",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine Succinate",
"start_marketing_date": "20040827",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code R06AA59.
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