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 29 of 34 · 675 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rite Aid Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE RITE AID CORPORATION 9889cf9e-3f6a-4abc-b723-0b295c7c8f93 2024-10-30 Warnings Exact identifier application number: M001 Rite Aid Pharmacy Extra Strength Assorted Berries CALCIUM CARBONATE RITE AID CORPORATION f697de02-7df9-4419-9835-8b65bbaf4215 2024-10-29 Warnings Exact identifier application number: M001 Premier Value Smooth Antacid Extra Strength Assorted Fruit ANTACID TABLETS Chain Drug Consortium 0de2c4c5-46fb-4081-aa96-b36794e3983f 2024-10-28 Warnings Exact identifier application number: M001 Premier Value Chewable Antacid Extra Strength Tropical Fruit ANTACID TABLETS Chain Drug Consortium 8999b9c1-05d0-496b-88f2-062908a4fadc 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Chewable Antacid Extra Strength Assorted Fruit ANTACID TABLETS Chain Drug Consortium ef8ab31b-d050-446a-bca9-4a94d4ba1752 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Extra Strength Original Flavor ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE PHARMACY VALUE ALLIANCE, LLC e33db45a-594e-4af8-ab16-10010fc8a388 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Extra Strength Freshmint Flavor CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE CHAIN DRUG CONSORTIUM, LLC 1192ebeb-f6cc-45db-8f07-12d36eb55a5f 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Maximum Strength Assorted Fruit CALCIUM CARBONATE, SIMETHICONE PHARMACY VALUE ALLIANCE, LLC e25bf9ca-415b-4a3e-a502-59074308da54 2024-10-25 Warnings Exact identifier application number: M001 PV Extra Strength Antacid CALCIUM CARBONATE PHARMACY VALUE ALLIANCE, LLC 8c92de83-ed60-46c3-b289-4b45a1915e24 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Chewable Antacid Ultra Strength Assorted Fruit ANTACID TABLETS Chain Drug Consortium 26c742a7-5806-44e0-bef0-c70a9d77dd23 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Chewable Antacid Assorted Fruit ANTACID TABLETS Chain Drug Consortium, LLC 00a58373-77ab-4a46-9862-d179e17c731a 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Multi Symptom Antacid Berry Flavor CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE Pharmacy Value Alliance LLC 69e0c4a8-04ae-461b-bf47-4180bccd91d6 2024-10-25 Warnings Exact identifier application number: M001 Premier Value Regular Strength Chewable Antacid Peppermint Assorted Fruit ANTACID TABLETS Chain Drug Consortium, LLC 245e195f-fd67-497b-83d4-fef75cea8b5b 2024-10-25 Warnings Exact identifier application number: M001 OHTAS ISAN ANTACID CALCIUM CARBONATE, SODIUM BICARBONATE OHTA'S ISAN CO.,LTD. 53380470-5748-6fa7-548e-7484ef204c0f 2024-10-21 Warnings Exact identifier application number: M001 OHTAS ISAN ANTACID CALCIUM CARBONATE, SODIUM BICARBONATE OHTA'S ISAN CO.,LTD. 8723fe90-8402-4511-b6c6-b71cf98513e3 2024-10-21 Warnings Exact identifier application number: M001 Citrus Flavored Antacid CALCIUM CARBONATE JHK DBA American Safety & First Aid 79f2b495-a438-408e-9572-b6c3516db52c 2024-10-15 Warnings Exact identifier application number: M001 NUTRALOX CALCIUM CARBONATE A-S Medication Solutions 524e26a9-c69f-4e25-b83d-f4c65adca83d 2024-10-11 Warnings Exact identifier application number: M001 Mag-AL Liquid ALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDE PAI Holdings, LLC b1f2d137-f5f7-4800-a1df-ef5d25544bc9 2024-10-08 Warnings Exact identifier application number: M001 Melox ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Belmora LLC bfc78d44-dc90-4f69-85af-a23dd70c68d2 2024-10-04 Warnings Exact identifier application number: M001 HEB Extra Strength sugar free Antacid 174 CALCIUM CARBONATE H E B 17cd3717-2fc3-1693-e063-6394a90ae03d 2024-09-17 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