Home NDC 0904-7557 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Product NDC 0904-7557
11-digit product format 009047557
Labeler code 0904
Product ID 0904-7557_a1959779-7777-44f0-b9bc-2dcab570365e
Type HUMAN OTC DRUG
Nonproprietary name Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Major Pharmaceuticals
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-07
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 1200; 1200; 120 mg/30mL; mg/30mL; mg/30mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 1200 mg/30mL MAGNESIUM HYDROXIDE 1200 mg/30mL DIMETHICONE 120 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QB0T2IUN0 Internal UNII lookup NBZ3QY004S Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307746 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7557-62 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 30 mL in 1 CUP, UNIT-DOSE SUSPENSION 30 10 0904-7557-73 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 10 in 1 TRAY SUSPENSION 10 10 0904-7557-73 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 10 in 1 CASE SUSPENSION 10 10
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 10 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7557-62 00904755762 30 mL in 1 CUP, UNIT-DOSE 30 ml Historical 0904-7557-73 00904755773 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) 10 tray 2025-07-07 No No Current