aluminum hydroxide, magnesium hydroxide and simethicone suspension

Generic: aluminum hydroxide, magnesium hydroxide, and simethicone

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name aluminum hydroxide, magnesium hydroxide and simethicone suspension
Generic Name aluminum hydroxide, magnesium hydroxide, and simethicone
Labeler major pharmaceuticals
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

aluminum hydroxide 1200 mg/30mL, dimethicone, unspecified 120 mg/30mL, magnesium hydroxide 1200 mg/30mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7325
Product ID 0904-7325_c4f8e03f-05b6-4a4b-a737-b797d1449a7b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M001
Marketing Start 2023-07-05
Marketing End 2026-04-30

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 09047325
Hyphenated Format 0904-7325

Supplemental Identifiers

RxCUI
237870 307746
UPC
0309047326624 0309047325627
UNII
5QB0T2IUN0 92RU3N3Y1O NBZ3QY004S

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 aluminum hydroxide, magnesium hydroxide and simethicone suspension (source: ndc)
Generic Name aluminum hydroxide, magnesium hydroxide, and simethicone (source: ndc)
Application Number M001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/30mL
  • 120 mg/30mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0904-7325-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7325-62)
source: ndc

Packages (1)

0904-7325-73 10 TRAY in 1 CASE (0904-7325-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7325-62)

Ingredients (3)

aluminum hydroxide (1200 mg/30mL) dimethicone, unspecified (120 mg/30mL) magnesium hydroxide (1200 mg/30mL)

Linked Drug Pages (1)

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c4f8e03f-05b6-4a4b-a737-b797d1449a7b", "openfda": {"upc": ["0309047326624", "0309047325627"], "unii": ["5QB0T2IUN0", "92RU3N3Y1O", "NBZ3QY004S"], "rxcui": ["237870", "307746"], "spl_set_id": ["0cab04e3-8b95-48bd-8bd0-2f7fef4addc0"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0904-7325-73)  / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7325-62)", "package_ndc": "0904-7325-73", "marketing_end_date": "20260430", "marketing_start_date": "20230801"}], "brand_name": "Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension", "product_id": "0904-7325_c4f8e03f-05b6-4a4b-a737-b797d1449a7b", "dosage_form": "SUSPENSION", "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": "0904-7325", "generic_name": "Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension", "active_ingredients": [{"name": "ALUMINUM HYDROXIDE", "strength": "1200 mg/30mL"}, {"name": "DIMETHICONE, UNSPECIFIED", "strength": "120 mg/30mL"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "1200 mg/30mL"}], "application_number": "M001", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260430", "marketing_start_date": "20230705"}