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United States · US · US:79903-116_f6ae2fa7-3ea7-4643-8bce-75b3a4f2558f
Anti-Diarrheal/Anti-Gas Multi-Symptom Relief
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWal-Mart Stores, Inc.
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1179903116334 BLISTER PACK in 1 CARTON (79903-116-33) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A214541
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"46f5c653-eec2-4729-8aaa-79f2e188eac3": {
"match": "brand_token",
"title": "ANTI-DIARRHEAL/ANTI-GAS CAPLETS (LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG) TABLET [YYBA CORP]",
"spl_version": "1",
"published_date": "2025-08-21"
}
},
"productid": "79903-116_f6ae2fa7-3ea7-4643-8bce-75b3a4f2558f",
"productndc": "79903-116",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214541",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "May 27, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Anti-Diarrheal/Anti-Gas Multi-Symptom Relief",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214541",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride 2mg, Simethicone 125mg",
"start_marketing_date": "20220715",
"active_numerator_strength": "125; 2"
}Related drugs
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