Home NDC 57896-615 Gentle Laxative
Product NDC 57896-615
11-digit product format 578960615
Labeler code 57896
Product ID 57896-615_1c46146c-1b7f-ea5f-e063-6294a90ac6db
Type HUMAN OTC DRUG
Nonproprietary name magnesium hydroxide
Dosage form LIQUID
Route ORAL
Labeler GERI-CARE PHARMACEUTICALS, CORP
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance MAGNESIUM HYDROXIDE
Active strength 1200 mg/15mL
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], 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 Gentle Laxative
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM HYDROXIDE 1200 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NBZ3QY004S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253017 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 57896-615-12 Gentle Laxative 355 mL in 1 BOTTLE LIQUID 355 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-615 GENTLE LAXATIVE (MAGNESIUM HYDROXIDE) LIQUID [GERI-CARE PHARMACEUTICALS, CORP] 1 Current NDC, 1 package rows 20240704_1c462af8-af1a-391c-e063-6394a90a8b49.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 14 of 42 · 833 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 57896-615-12 57896061512 355 mL in 1 BOTTLE (57896-615-12) 355 ml 2024-04-01 No No Current