Home NDC 53145-390-04 Sodium Bicarbonate Antacid
Product NDC 53145-390
Requested package NDC 53145-390-04
11-digit product format 531450390
Labeler code 53145
Product ID 53145-390_3a8afea2-5d9e-1392-e063-6294a90aca43
Type HUMAN OTC DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form POWDER
Route ORAL
Labeler Menper Distributors Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-01
Substance SODIUM BICARBONATE
Active strength 2.616 g/2.616g
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Sodium Bicarbonate Antacid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM BICARBONATE 2.616 g/2.616g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8MDF5V39QO Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-390-04 Sodium Bicarbonate Antacid 113 g in 1 BOTTLE POWDER 113 3 53145-390-08 Sodium Bicarbonate Antacid 227 g in 1 BOTTLE POWDER 227 3 53145-390-16 Sodium Bicarbonate Antacid 454 g in 1 BOTTLE POWDER 454 3
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 38 · 747 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Stomach Relief CALCIUM CARBONATE Wal-Mart Stores Inc 7471ec99-6c0b-40d8-a9cf-85240a0d471a 2026-09-09 Warnings Exact identifier application number: M001 Walgreens Orange Antacid Soft Chew CALCIUM CARBONATE Walgreens 5b01be31-5871-d4f5-e063-6294a90a671a 2026-09-08 Warnings Exact identifier application number: M001 Regular Strength Tropical Fruit CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 38c6cece-71a0-40d8-bfc8-2f6467f9239b 2026-09-05 Warnings Exact identifier application number: M001 Extra Strength Antacid Assorted Berries CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 07a50168-6b05-4c99-9969-7d7f0aa54f30 2026-09-05 Warnings Exact identifier application number: M001 DRx CHOICE Antacid Calcium Regular Strength CALCIUM CARBONATE 500MG Raritan Pharmaceuticals Inc 0c579405-9397-4bf2-8441-e89011b19ec4 2026-09-05 Warnings Exact identifier application number: M001 Tums Chewy Bites Wintermint and Vanilla Cream CALCIUM CARBONATE Haleon US Holdings LLC 4f094feb-8de1-4ccb-e063-6294a90acec2 2026-09-04 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE DOLGENCORP, LLC 98a0503c-add5-4453-9d9d-6f813866f4b3 2026-09-03 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE DOLGENCORP, LLC 99c7ab95-df12-4041-ae1a-398cc6f0085d 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Ultra Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Liquid Antacid plus Anti Gas CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE DOLGENCORP, LLC 8ecb4418-e647-49b5-b418-1c63bb3e5a3c 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 4942747a-8b6c-422a-8150-9bd91c0a3778 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Regular Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC 13dd2758-a372-4b0e-bc99-56a2dacbf95f 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid Wintergreen flavor CALCIUM CARBONATE DOLGENCORP, LLC b84b3509-3178-4616-9bec-dad85a4f9d2a 2026-09-03 Warnings Exact identifier application number: M001 DG Health Regular Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 59ad3cc7-4144-442f-a37d-75c5fe23e1ae 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Assorted Fruits Antacid CALCIUM CARBONATE DOLGENCORP, LLC 112f1002-c007-4363-ade6-8dfbc61f4b64 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid SMOOTH DISSOLVE CALCIUM CARBONATE DOLGENCORP, LLC cabaa8f7-9c93-439d-905a-5ef643a08ea8 2026-09-03 Warnings Exact identifier application number: M001 Kroger Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE THE KROGER CO., 175d9f0f-266a-4dc2-865f-d1ebd4ddac51 2026-09-01 Warnings Exact identifier application number: M001 Kids Antacid CALCIUM CARBONATE THE KROGER CO. d77c629b-5308-4b71-9024-9899cf88dbae 2026-09-01 Warnings Exact identifier application number: M001 Kroger Extra Strength Smooth Antacid Assorted Berry CALCIUM CARBONATE KROGER COMPANY 4c8d39d9-9d58-45df-9ffd-2cdc41539c03 2026-09-01 Warnings Exact identifier application number: M001 Kroger Ultra Strength Assorted Fruit CALCIUM CARBONATE KROGER COMPANY b60ced06-725c-4dae-abbf-21cab9e431f9 2026-08-31 Warnings Exact identifier application number: M001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53145-390-04 53145039004 113 g in 1 BOTTLE (53145-390-04) 113 g 2017-01-01 No No Current