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United States · US · US:41520-634_e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7
CareOne Nighttime Sleep Aid
In shortageOrange BookUNIISPLATC R06AA59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeR06AA59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11415206346432 BLISTER PACK in 1 CARTON (41520-634-64) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040167
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": {
"206f5483-7de1-4bc3-af27-190e211bcb95": {
"match": "brand_token",
"title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "41520-634_e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7",
"productndc": "41520-634",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040167",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 18, 1996"
}
],
"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": "CareOne Nighttime Sleep Aid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040167",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine succinate",
"start_marketing_date": "20160506",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code R06AA59.
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