🇺🇸
United States · US · US:76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6
Topcare Sleep Aid
In shortageOrange BookUNIISPLATC R06AA59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR06AA59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11761621596224 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACK
- ndc11761621596748 BLISTER PACK in 1 CARTON (76162-159-67) / 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": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6",
"productndc": "76162-159",
"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": "Topcare Sleep Aid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040167",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxylamine Succinate",
"start_marketing_date": "20230616",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code R06AA59.
Access this data programmatically
Query Topcare Sleep Aid and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.