Home NDC 68391-033 BERKLEY JENSEN
Product NDC 68391-033
11-digit product format 683910033
Labeler code 68391
Product ID 68391-033_c7eedcbf-3b07-4cd3-937b-c56d7cc5bc57
Type HUMAN OTC DRUG
Nonproprietary name ANTACID CALCIUM CARBONATE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler BJWC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-17
Substance CALCIUM CARBONATE
Active strength 1000 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 BERKLEY JENSEN
Brand name suffix ULTRA STRENGTH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 1000 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 308892 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 68391-033-65 BERKLEY JENSENULTRA STRENGTH 265 in 1 BOTTLE TABLET, CHEWABLE 265 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-033 BERKLEY JENSEN ULTRA STRENGTH (ANTACID CALCIUM CARBONATE) TABLET, CHEWABLE [BJWC] 1 Current NDC, 1 package rows 20250410_c7eedcbf-3b07-4cd3-937b-c56d7cc5bc57.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 36 · 719 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 68391-033-65 68391003365 265 TABLET, CHEWABLE in 1 BOTTLE (68391-033-65) 2025-03-17 No No Current