anti-diarrheal/anti-gas

Generic: loperamide hydrochloride, simethicone

Labeler: discount drug mart, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal/anti-gas
Generic Name loperamide hydrochloride, simethicone
Labeler discount drug mart, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1, loperamide hydrochloride 2 mg/1

Manufacturer
Discount Drug Mart, Inc

Identifiers & Regulatory

Product NDC 53943-263
Product ID 53943-263_e44c3937-4a74-46c4-a467-398229e5aece
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214541
Listing Expiration 2026-12-31
Marketing Start 2025-02-26

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53943263
Hyphenated Format 53943-263

Supplemental Identifiers

RxCUI
978001
UPC
0093351033209
UNII
92RU3N3Y1O 77TI35393C
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name anti-diarrheal/anti-gas (source: ndc)
Generic Name loperamide hydrochloride, simethicone (source: ndc)
Application Number ANDA214541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

53943-263-33 4 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

dimethicone (125 mg/1) loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Anti-Diarrheal/Anti-Gas ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e44c3937-4a74-46c4-a467-398229e5aece", "openfda": {"nui": ["N0000010282"], "upc": ["0093351033209"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["2e0b3aec-f436-c0fb-e063-6394a90abb51"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Discount Drug Mart, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (53943-263-33)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "53943-263-33", "marketing_start_date": "20250226"}], "brand_name": "Anti-Diarrheal/Anti-Gas", "product_id": "53943-263_e44c3937-4a74-46c4-a467-398229e5aece", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "53943-263", "generic_name": "Loperamide Hydrochloride, Simethicone", "labeler_name": "Discount Drug Mart, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-Diarrheal/Anti-Gas", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA214541", "marketing_category": "ANDA", "marketing_start_date": "20250226", "listing_expiration_date": "20261231"}