gelusil

Generic: alumina, magnesia, simethicone

Labeler: wellspring pharmaceutical corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gelusil
Generic Name alumina, magnesia, simethicone
Labeler wellspring pharmaceutical corporation
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

aluminum hydroxide 200 mg/1, dimethicone, unspecified 24 mg/1, magnesium hydroxide 200 mg/1, silicon dioxide 1 mg/1

Manufacturer
WellSpring Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 65197-300
Product ID 65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M001
Listing Expiration 2026-12-31
Marketing Start 2008-09-24

Pharmacologic Class

Classes
calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] skin barrier activity [pe] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65197300
Hyphenated Format 65197-300

Supplemental Identifiers

RxCUI
211633 307747
UPC
0365197300112
UNII
5QB0T2IUN0 92RU3N3Y1O NBZ3QY004S ETJ7Z6XBU4

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 gelusil (source: ndc)
Generic Name alumina, magnesia, simethicone (source: ndc)
Application Number M001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 24 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)
source: ndc

Packages (2)

65197-300-10 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 65197-300-11 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)

Ingredients (4)

aluminum hydroxide (200 mg/1) dimethicone, unspecified (24 mg/1) magnesium hydroxide (200 mg/1) silicon dioxide (1 mg/1)

Linked Drug Pages (1)

Gelusil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4406bf6b-b261-c6e1-e063-6294a90ae101", "openfda": {"upc": ["0365197300112"], "unii": ["5QB0T2IUN0", "92RU3N3Y1O", "NBZ3QY004S", "ETJ7Z6XBU4"], "rxcui": ["211633", "307747"], "spl_set_id": ["92fbeec1-1562-40f3-9734-41f133d494f9"], "manufacturer_name": ["WellSpring Pharmaceutical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65197-300-10)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "65197-300-10", "marketing_start_date": "20080924"}, {"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)", "package_ndc": "65197-300-11", "marketing_start_date": "20181201"}], "brand_name": "Gelusil", "product_id": "65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Calculi Dissolution Agent [EPC]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Skin Barrier Activity [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "65197-300", "generic_name": "Alumina, Magnesia, Simethicone", "labeler_name": "WellSpring Pharmaceutical Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gelusil", "active_ingredients": [{"name": "ALUMINUM HYDROXIDE", "strength": "200 mg/1"}, {"name": "DIMETHICONE, UNSPECIFIED", "strength": "24 mg/1"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "200 mg/1"}, {"name": "SILICON DIOXIDE", "strength": "1 mg/1"}], "application_number": "M001", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080924", "listing_expiration_date": "20261231"}