aluminum hydroxide, magnesium hydroxide, and simethicone

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

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

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7557
Product ID 0904-7557_a1959779-7777-44f0-b9bc-2dcab570365e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M001
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047557
Hyphenated Format 0904-7557

Supplemental Identifiers

RxCUI
307746
UPC
0309047557622
UNII
5QB0T2IUN0 92RU3N3Y1O NBZ3QY004S
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 aluminum hydroxide, magnesium hydroxide, and simethicone (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 (0904-7557-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7557-62)
source: ndc

Packages (1)

0904-7557-73 10 TRAY in 1 CASE (0904-7557-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7557-62)

Ingredients (3)

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

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a1959779-7777-44f0-b9bc-2dcab570365e", "openfda": {"nui": ["N0000010282"], "upc": ["0309047557622"], "unii": ["5QB0T2IUN0", "92RU3N3Y1O", "NBZ3QY004S"], "rxcui": ["307746"], "spl_set_id": ["1bc90fa7-fcce-4a9b-862f-f30ab602ecab"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0904-7557-73)  / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7557-62)", "package_ndc": "0904-7557-73", "marketing_start_date": "20250707"}], "brand_name": "Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone", "product_id": "0904-7557_a1959779-7777-44f0-b9bc-2dcab570365e", "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": "0904-7557", "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", "active_ingredients": [{"name": "ALUMINUM HYDROXIDE", "strength": "1200 mg/30mL"}, {"name": "DIMETHICONE", "strength": "120 mg/30mL"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "1200 mg/30mL"}], "application_number": "M001", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}