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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6efb4da0-03ae-4df6-acd7-e8023d20d4b3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-390-04	2020-01-31	C162847	48780-1	9d75b9d1-0fdb-f424-e053-dadaa90a57ce	Sodium Bicarbonate Antacid
53145-390-08	2020-01-31	C162847	48780-1	9d75b9d1-0fdb-f424-e053-dadaa90a57ce	Sodium Bicarbonate Antacid
53145-390-16	2020-01-31	C162847	48780-1	9d75b9d1-0fdb-f424-e053-dadaa90a57ce	Sodium Bicarbonate Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 27 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tums Chewy Bites	CALCIUM CARBONATE	Navajo Manufacturing Company Inc.	297d6703-ed4e-10d3-e063-6394a90a9f3a	2024-12-17	Warnings	Exact identifier application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)	CALCIUM CARBONATE 10GR (648 MG)	RUGBY LABORATORIES	f21c8cf7-45cb-492b-bf4a-462024a54569	2024-12-17	Warnings	Exact identifier application number: M001
Extra Strength Antacid Tablets, Caseys 4good	CALCIUM CARBONATE 750 MG	Lil' Drug Store Prodsucts, Inc.	026aefd6-bb80-1ffd-e063-6394a90a1262	2024-12-16	Warnings	Exact identifier application number: M001
Foster and Thrive Regular Strength Antacid	CALCIUM CARBONATE	Strategic Sourcing Services LLC	1aeb60fb-eebe-4e54-be1c-4e01f3b7269c	2024-12-13	Warnings	Exact identifier application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Strategic Sourcing Services LLC	8b2fabf7-4dc6-445a-842c-b28ae081fdc8	2024-12-13	Warnings	Exact identifier application number: M001
Foster and Thrive Regular Strength Antacid Peppermint	CALCIUM CARBONATE	Strategic Sourcing Services LLC	49d1b6c4-432b-44d3-b073-0185dbed7a90	2024-12-12	Warnings	Exact identifier application number: M001
Mylanta Maximum Strength Classic Flavor	ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	56853b20-a2aa-4b19-a428-3dde232114c6	2024-12-11	Warnings	Exact identifier application number: M001
Mylanta New Tonight Soothing Honey Chamomile	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	123f3005-a0a0-4970-94f1-f6d04741078b	2024-12-11	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	NuCare Pharmaceuticals, Inc.	fd160cfd-9ad4-81c7-e053-6394a90a33f6	2024-12-11	Warnings	Exact identifier application number: M001
Topcare Ultra Strength Antacid Peppermint	CALCIUM CARBONATE	Topco Associates, LLC	fb434059-7b6e-42e0-acfa-db9879f6a4e4	2024-12-11	Warnings	Exact identifier application number: M001
TopCare Ultra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Topco Associates, LLC	dd038b15-2ecb-4ee2-b356-db6d87c2f01b	2024-12-11	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	74823298-d24a-4ffe-8446-1661305372b2	2024-12-11	Warnings	Exact identifier application number: M001
Extra Strength Antacid Smooth Dissolve Assorted Fruit	CALCIUM CARBONATE	UNITED NATURAL FOODS, INC. DBA UNFI	1b6a48a7-0703-2d3d-e063-6394a90a4641	2024-12-11	Warnings	Exact identifier application number: M001
Careone Regular Strength Calcium Antacid	CALCIUM CARBONATE	Retail Business Services, LLC.	bdd9a64d-777b-45e0-8a9a-6cdc54baf898	2024-12-11	Warnings	Exact identifier application number: M001
Careone Regular Strength calcium Antacid	CALCIUM CARBONATE	Retail Business Services, LLC.	cb6e12cc-4b88-4046-a9fc-2dbe4bca965e	2024-12-11	Warnings	Exact identifier application number: M001
TopCare Ultra Strength Antacid Assorted Berry	CALCIUM CARBONATE	Topco Associates, LLC	c10c56ba-51cf-47f9-80a8-aa188859608f	2024-12-11	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Retail Business Services, LLC.	ce2edc57-e550-4aa9-bbfe-37933913c9eb	2024-12-11	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	b8712a98-30b7-4154-a5bf-0095ef901412	2024-12-09	Warnings	Exact identifier application number: M001
HEARTBURN RELIEF	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	GERI-CARE PHARMACEUTICALS, CORP	1f1dbf41-cb87-37d4-e063-6394a90ae294	2024-12-09	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	25c93d2a-3c48-ca3a-e063-6294a90a312e	2024-12-09	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Bicarbonate Antacid	Menper Distributors Inc. \| Church & Dwight Co., Inc.	2025-07-22	HUMAN OTC DRUG LABEL	3