🇺🇸
United States · US · US:50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e
Imodium
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115058013404120 mL in 1 BOTTLE (50580-134-04)
- ndc115058013408240 mL in 1 BOTTLE (50580-134-08)
- ndc115058013444120 mL in 1 BOTTLE (50580-134-44)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
N019487
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": {
"ecb91e47-2b0c-47c8-9256-4623d8bc825e": {
"match": "brand_token",
"title": "IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [KENVUE BRANDS LLC]",
"spl_version": "23",
"published_date": "2026-01-30"
}
},
"productid": "50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e",
"productndc": "50580-134",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "019487",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG/5ML",
"product_no": "001",
"approval_date": "Mar 1, 1988"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG/7.5ML",
"product_no": "002",
"approval_date": "Jul 8, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Imodium",
"active_ingred_unit": "mg/7.5mL",
"application_number": "NDA019487",
"marketing_category": "NDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20040701",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC
- 🇺🇸anti diarrhealH E B
- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealKroger Company
- 🇺🇸anti diarrhealCVS Pharmacy
- 🇺🇸anti diarrhealHyVee Inc
- 🇺🇸anti diarrhealPublix Super Markets Inc
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