🇺🇸
United States · US · US:41520-772_81170c0a-6219-4612-af10-a46d1858e3e3
CareOne Diarrhea and Gas Control
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11415207725312 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "41520-772_81170c0a-6219-4612-af10-a46d1858e3e3",
"productndc": "41520-772",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209837",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Sep 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "CareOne Diarrhea and Gas Control",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209837",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride, simethicone",
"start_marketing_date": "20190131",
"active_numerator_strength": "125; 2"
}Related drugs
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