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 34 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXIMUM STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	WAL-MART STORES, INC.	7cc2ad32-fdff-0772-e053-2a91aa0aad9e	2023-11-01	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID CHERRY	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	WAL-MART STORES, INC.	7cc2771e-abd7-4120-e053-2a91aa0a8af0	2023-11-01	Warnings	Exact identifier application number: M001
MINTOX MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Proficient Rx LP	b7711b50-c14a-44d6-b647-1f31284f87ea	2023-11-01	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	VALU MERCHANDISERS COMPANY	5e811783-cbf6-d0e3-e053-2991aa0ae69f	2023-10-31	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS	5f880b43-2977-7a2d-e053-2991aa0a024d	2023-10-31	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS PHARMACY	d5661964-9d2c-7a3d-e053-2995a90a86ef	2023-10-31	Warnings	Exact identifier application number: M001
EXTRA STRENGTH HEARTBURN RELIEF	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	CVS PHARMACY,INC.	53fc327e-e345-26f2-e054-00144ff8d46c	2023-10-31	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRY	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	VALU MERCHANDISERS COMPANY	5e94cb90-b616-dcfe-e053-2a91aa0ada72	2023-10-31	Warnings	Exact identifier application number: M001
CALCIUM CARBONATE CHEWABLE ANTACID	CALCIUM CARBONATE	Geri-Care Pharmaceutical Corp	27d9b505-08bd-4261-a59d-6ddc4031be32	2023-10-25	Warnings	Exact identifier application number: M001
CALCIUM CARBONATE	CALCIUM CARBONATE	Blessings International	99d7e467-a3db-b4f0-e053-2a95a90a900f	2023-10-25	Warnings	Exact identifier application number: M001
Sodium Bicarbonate	SODIUM BICARBONATE	APNAR PHARMA LP	e206c240-55c2-2d00-e053-2a95a90a1779	2023-10-21	Boxed warning, Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	APNAR PHARMA LP	e4ef2224-07e4-e913-e053-2995a90a28ed	2023-10-21	Warnings	Exact identifier application number: M001
Magnesium Oxide 400mg	MAGNESIUM OXIDE 400MG	Allegiant Health	2ea68874-8c20-4284-bd0a-f07768057b83	2019-01-28	Warnings	Exact identifier application number: M001
Calcium Antacid	CALCIUM CARBONATE	Allegiant Health	51dd53e8-22ff-4967-9124-f15c3986e4dd	2017-11-17	Warnings	Exact identifier application number: M001
Calcium Antacid	CALCIUM CARBONATE	Allegiant Health	551d6135-2650-4c27-a20d-d56a9aba7b71	2017-11-08	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