Home NDC 53145-390 Sodium Bicarbonate Antacid
Product NDC 53145-390
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 2027-12-31
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-390-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-390-16 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-390-08 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-390-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-390-16 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-390-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-390-04 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-390-16 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-390-08 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-390-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-390-16 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-390-08 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-390-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-390-16 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-390-08 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-390-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-390-16 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-390-08 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-390-08 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-390-16 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-390-04 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Sodium Bicarbonate Antacid
Listing expiration 2027-12-31 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 23 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e0d5be6-d41b-cdf8-e063-6394a90a08b4 2025-02-27 Warnings Exact identifier application number: M001 Supreme Antacid Cherry CALCIUM CARBONATE, MAGNESIUM HYDROXIDE Discount Drug Mart, Inc 2e0a1913-c3d4-7c7d-e063-6294a90a4841 2025-02-26 Warnings Exact identifier application number: M001 Extra Strength sugar free Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e09f87b-c771-59ae-e063-6294a90a0c39 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Wintergreen Flavor CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 409b5d06-3398-4414-8919-10b9064ba4ee 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2df92d5c-cd5a-060b-e063-6394a90aa51f 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2e09cb3b-cf5d-15b1-e063-6394a90a5c6a 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Smooth Assorted Fruit Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df86c35-1e9b-eb49-e063-6294a90aabb6 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Regular strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2dfa0de5-6e58-dc9d-e063-6294a90a53e0 2025-02-20 Warnings Exact identifier application number: M001 Childrens Tummy Relief CALCIUM CARBONATE Genexa Inc. f4d39d3e-82d0-2673-e053-2995a90a7d2a 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Peppermint Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df8fe2b-cc9a-f026-e063-6394a90aa0ad 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb4ce4e-e18c-c96d-e063-6394a90a18ca 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb60b7e-711a-8052-e063-6394a90acf1d 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df9e47a-8741-6958-e063-6394a90a6c60 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Discount Drug Mart, Inc 2e09b8d1-25b4-0e57-e063-6394a90a31e2 2025-02-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Orange and Cream ES CALCIUM CARBONATE Haleon US Holdings LLC 036ef1ed-32ef-46b8-8817-b3f63a014280 2025-02-14 Warnings Exact identifier application number: M001 Tums Naturals CALCIUM CARBONATE Haleon US Holdings LLC d8da54b8-6456-4e7d-acd2-a55e2249bd01 2025-02-13 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Harris Teeter, LLC 2cb4c58f-ee88-b60e-e063-6294a90a1e6c 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c4fc835-a9ad-2666-e063-6394a90a20ac 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c5081a6-367f-28bc-e063-6294a90a459e 2025-02-12 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Harris Teeter, LLC 2cb54a40-98ce-2660-e063-6294a90a3ed0 2025-02-11 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 53145-390-08 53145039008 227 g in 1 BOTTLE (53145-390-08) 227 g 2017-01-01 No No Current 53145-390-16 53145039016 454 g in 1 BOTTLE (53145-390-16) 454 g 2017-01-01 No No Current