Home NDC 68016-249 Premier Value Maximum Strength
Product NDC 68016-249
11-digit product format 680160249
Labeler code 68016
Product ID 68016-249_450c1e14-f3e9-46ec-a032-75d3cb6d2733
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate, Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler PHARMACY VALUE ALLIANCE, LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-22
Substance CALCIUM CARBONATE; DIMETHICONE, UNSPECIFIED
Active strength 1000; 60 mg/1; mg/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [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 Maximum Strength
Brand name suffix Assorted Fruit
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 1000 mg/1 DIMETHICONE, UNSPECIFIED 60 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 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 403828 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 68016-249-00 Premier Value Maximum StrengthAssorted Fruit 90 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-249 PREMIER VALUE MAXIMUM STRENGTH ASSORTED FRUIT (CALCIUM CARBONATE, SIMETHICONE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241028_e25bf9ca-415b-4a3e-a502-59074308da54.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 68016-249-00 68016024900 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68016-249-00) 2019-04-22 0000-00-00 No No Current