🇺🇸
United States · US · US:36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c
topcare anti diarrheal
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11368002245312 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11368002246224 BLISTER PACK in 1 CARTON (36800-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1136800224916 BLISTER PACK in 1 CARTON (36800-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A075232
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "77TI35393C",
"rxcui": "82038",
"inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
"display_name": "LOPERAMIDE HYDROCHLORIDE",
"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": "36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c",
"productndc": "36800-224",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075232",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Jan 6, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "topcare anti diarrheal",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075232",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20030226",
"active_numerator_strength": "2"
}Related drugs
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