Home NDC 53041-102 GDC Extra strength Alkums Antacid 127AF
Product NDC 53041-102
11-digit product format 530410102
Labeler code 53041
Product ID 53041-102_6a87e1e4-5e8e-4102-b693-5413b6659b87
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Guardian Drug Company
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-13
Substance CALCIUM CARBONATE
Active strength 750 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 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 GDC Extra strength Alkums Antacid 127AF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 750 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 308915 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 53041-102-13 GDC Extra strength Alkums Antacid 127AF 48 in 1 BOTTLE TABLET, CHEWABLE 48 2 53041-102-22 GDC Extra strength Alkums Antacid 127AF 96 in 1 BOTTLE TABLET, CHEWABLE 96 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-102 GDC EXTRA STRENGTH ALKUMS ANTACID 127AF (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY] 2 Current NDC, 2 package rows 20240815_1b6da4a3-cfa6-6d98-e063-6394a90a5889.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 Sample Exclude flag Status 53041-102-13 53041010213 48 TABLET, CHEWABLE in 1 BOTTLE (53041-102-13) 2024-08-13 No No Current 53041-102-22 53041010222 96 TABLET, CHEWABLE in 1 BOTTLE (53041-102-22) 2024-08-13 No No Current