Home NDC 68788-8506 Antacid
Product NDC 68788-8506
11-digit product format 687888506
Labeler code 68788
Product ID 68788-8506_a371c22c-8477-4e02-8c97-4473e6fd1456
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form LIQUID
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application part331
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-02
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED
Active strength 400; 400; 40 mg/10mL; mg/10mL; mg/10mL
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 Antacid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 400 mg/10mL MAGNESIUM HYDROXIDE 400 mg/10mL DIMETHICONE, UNSPECIFIED 40 mg/10mL
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 68788-8506-3 Antacid 355 mL in 1 BOTTLE LIQUID 355 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8506 ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, 1 package rows 20240806_a96496ff-4b35-4ebe-a6e4-bcfa48fb1341.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Preferred Pharmaceuticals Inc. a96496ff-4b35-4ebe-a6e4-bcfa48fb1341 2026-08-26 Warnings Exact identifier ndc (product): 68788-8506
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8506-3 68788850603 355 mL in 1 BOTTLE (68788-8506-3) 355 ml 2023-08-15 No No Current