Home NDC 71205-515 MINTOX MAXIMUM STRENGTH
Product NDC 71205-515
11-digit product format 712050515
Labeler code 71205
Product ID 71205-515_dddf9006-4715-487a-b12f-67d56a9e1993
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form SUSPENSION
Route ORAL
Labeler Proficient Rx LP
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-02-01
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 400; 400; 40 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 MINTOX MAXIMUM STRENGTH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 400 mg/5mL MAGNESIUM HYDROXIDE 400 mg/5mL DIMETHICONE 40 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237870 Internal RxNorm lookup 708127 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 71205-515-35 MINTOX MAXIMUM STRENGTH 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 71205-515 MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 1 package rows 20231111_b7711b50-c14a-44d6-b647-1f31284f87ea.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 13 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 71205-515-35 71205051535 355 mL in 1 BOTTLE (71205-515-35) 355 ml 2020-12-16 0000-00-00 No No Current