Home NDC 0395-0431 Calcium Carbonate
Product NDC 0395-0431
11-digit product format 003950431
Labeler code 0395
Product ID 0395-0431_0c92bb26-9051-5952-e063-6294a90a481c
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form POWDER
Route ORAL
Labeler Humco Holding Group, Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-01-01
Substance CALCIUM CARBONATE
Active strength 1 g/g
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 Calcium Carbonate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII 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 0395-0431-01 Calcium Carbonate 454 g in 1 BOTTLE, PLASTIC POWDER 454 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0431 CALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20231216_8b207b49-d3fd-4108-b611-dca27c9dc78a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-0431-01 00395043101 454 g in 1 BOTTLE, PLASTIC (0395-0431-01) 454 g 2017-11-13 0000-00-00 No No Current