🇺🇸
United States · US · US:53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f
Loperamide Hydrochloride, Simethicone
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGuardian Drug Company
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1153041263501 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A214541
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"0b1f8d41-51b3-4362-8de7-46bca5caff12": {
"match": "brand_token",
"title": "LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "6",
"published_date": "2026-06-01"
}
},
"productid": "53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f",
"productndc": "53041-263",
"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": "Loperamide Hydrochloride, Simethicone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214541",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride, Simethicone",
"start_marketing_date": "20210601",
"active_numerator_strength": "125; 2"
}Related drugs
Other records sharing ATC code P03AX.
- 🇺🇸ABC Arbonne Baby Care Diaper RashArbonne International, LLC
- 🇺🇸AD Treat Diaper Rash Cream with Dimethicone and Zinc OxideWellSpring Pharmaceutical Corporation
- 🇺🇸ADVANCED ANTACID MINTGOODSENSE
- 🇺🇸ADVANCED REGULAR STRENGTH ANTACIDWALGREEN COMPANY
- 🇺🇸Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchBayer HealthCare LLC.
- 🇺🇸Alka-Seltzer Kids Tummy ReliefChewsBayer HealthCare LLC.
- 🇺🇸ALMACONE DOUBLE STRENGTHRUGBY LABORATORIES
- 🇺🇸Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeRising Pharma Holdings, Inc.
Access this data programmatically
Query Loperamide Hydrochloride, Simethicone 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.