Home NDC 68016-678 Premier Value Extra Strength
Product NDC 68016-678
11-digit product format 680160678
Labeler code 68016
Product ID 68016-678_38ac34e7-3a06-4719-a8a5-9c5dcd755133
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate ,Magnesium Hydroxide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler CHAIN DRUG CONSORTIUM, LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-18
Substance CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength 675; 135 mg/1; mg/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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 Premier Value Extra Strength
Brand name suffix Freshmint Flavor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 675 mg/1 MAGNESIUM HYDROXIDE 135 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup 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 476549 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 68016-678-00 Premier Value Extra StrengthFreshmint Flavor 100 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-678 PREMIER VALUE EXTRA STRENGTH FRESHMINT FLAVOR (CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241028_1192ebeb-f6cc-45db-8f07-12d36eb55a5f.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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68016-678-00 68016067800 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68016-678-00) 2019-04-18 0000-00-00 No No Current