Home NDC 67618-102 Colace Fast-Acting Saline Laxative
Product NDC 67618-102
11-digit product format 676180102
Labeler code 67618
Product ID 67618-102_1320a918-d279-411a-b08a-47b4012094d0
Type HUMAN OTC DRUG
Nonproprietary name Magnesium hydroxide
Dosage form CAPSULE
Route ORAL
Labeler Atlantis Consumer Healthcare, Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-16
Substance MAGNESIUM HYDROXIDE
Active strength 800 mg/1
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 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 Colace Fast-Acting Saline Laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM HYDROXIDE 800 mg/1
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 2738919 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 67618-102-60 Colace Fast-Acting Saline Laxative 1 in 1 CARTON CAPSULE 1 1 67618-102-60 Colace Fast-Acting Saline Laxative 60 in 1 BOTTLE, PLASTIC CAPSULE 60 1
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 Marketing start Sample Exclude flag Status 67618-102-60 67618010260 1 BOTTLE, PLASTIC in 1 CARTON (67618-102-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC 2026-03-16 No No Current