Home NDC 53041-098 Guardian Regular Strength Alkums
Product NDC 53041-098
11-digit product format 530410098
Labeler code 53041
Product ID 53041-098_281729d2-7257-4ea1-8c6a-ec4e9ff8b6fa
Type HUMAN OTC DRUG
Nonproprietary name Calcium carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Guardian Drug Company
Application part331
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-05
Substance CALCIUM CARBONATE
Active strength 500 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Guardian Regular Strength Alkums
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 500 mg/1
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308907 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 53041-098-17 Guardian Regular Strength Alkums 150 in 1 BOTTLE TABLET, CHEWABLE 150 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-098 GUARDIAN REGULAR STRENGTH ALKUMS (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY] 2 Current NDC, Legacy NDC, 1 package rows 20231202_d7df3e77-2f9a-4f81-864e-7647b1ccb57d.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.
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 53041-098-17 53041009817 150 TABLET, CHEWABLE in 1 BOTTLE (53041-098-17) 2021-10-05 0000-00-00 No No Current