Home NDC 27854-115 Melox
Product NDC 27854-115
11-digit product format 278540115
Labeler code 27854
Product ID 27854-115_54fbe2ae-c375-4a87-bee6-d1abf60360c0
Type HUMAN OTC DRUG
Nonproprietary name Aluminum hydroxide, Magnesium hydroxide, Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Belmora LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-01
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED
Active strength 200; 200; 20 mg/5mL; mg/5mL; mg/5mL
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 2027-12-31
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 Melox
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 200 mg/5mL MAGNESIUM HYDROXIDE 200 mg/5mL DIMETHICONE, UNSPECIFIED 20 mg/5mL
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 27854-115-01 Melox 355 mL in 1 BOTTLE SUSPENSION 355 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27854-115 MELOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [BELMORA LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241009_d41f0b26-5add-4045-9754-37d70d120d28.zip
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 8 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 Marketing end Sample Exclude flag Status 27854-115-01 27854011501 355 mL in 1 BOTTLE (27854-115-01) 355 ml 2018-06-01 0000-00-00 No No Current