Home NDC 57896-565 HEARTBURN RELIEF
Product NDC 57896-565
11-digit product format 578960565
Labeler code 57896
Product ID 57896-565_28d955ae-eec6-64fc-e063-6294a90a154d
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide and magnesium carbonate
Dosage form SUSPENSION
Route ORAL
Labeler GERI-CARE PHARMACEUTICALS, CORP
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
Substance ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength 254; 237.5 mg/5mL; mg/5mL
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 HEARTBURN RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 254 mg/5mL MAGNESIUM CARBONATE 237.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QB0T2IUN0 Internal UNII lookup 0E53J927NA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245001 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 57896-565-12 HEARTBURN RELIEF 355 mL in 1 BOTTLE SUSPENSION 355 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-565 HEARTBURN RELIEF (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) SUSPENSION [GERI-CARE PHARMACEUTICALS, CORP] 2 Current NDC, 1 package rows 20241210_1f1dbf41-cb87-37d4-e063-6394a90ae294.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 19 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 57896-565-12 57896056512 355 mL in 1 BOTTLE (57896-565-12) 355 ml 2024-07-01 No No Current