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 30 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodsense Extra Strength Antacid	CALCIUM CARBONATE	GoodSense	193a1805-9f57-29cd-e063-6394a90ab99f	2024-09-13	Warnings	Exact identifier application number: M001
QCH Maximum Strength Antacid 516	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	1794c35a-79c5-48c2-e063-6394a90a6d29	2024-08-28	Warnings	Exact identifier application number: M001
QCH Regular Strength Antacid 509	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	17947ccd-6f11-d4cd-e063-6294a90a108a	2024-08-27	Warnings	Exact identifier application number: M001
Regular Strength Antacid Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	17dfe539-923b-e623-e063-6294a90a041f	2024-08-27	Warnings	Exact identifier application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHR	SIMETHICONE	Chain Drug Marketing Association Inc.	17e3300c-3d31-b7e1-e063-6294a90af082	2024-08-27	Warnings	Exact identifier application number: M001
Quality Choice Infants Non-staining Gas relief	SIMETHICONE	Chain Drug Marketing Association Inc.	17e181e5-6527-54d0-e063-6294a90addc2	2024-08-23	Warnings	Exact identifier application number: M001
Tums Chewy Bites	CALCIUM CARBONATE	Haleon US Holdings LLC	72ac000c-90f7-42e2-88a6-740de114a954	2024-08-21	Warnings	Exact identifier application number: M001
GDC Extra strength Alkums Antacid 127AF	CALCIUM CARBONATE	Guardian Drug Company	1b6da4a3-cfa6-6d98-e063-6394a90a5889	2024-08-13	Warnings	Exact identifier application number: M001
Wonderbelly Maximum Strength Antacid - Sweet Mint	CALCIUM CARBONATE	Ginger Health Company	17ddf76b-237a-eeee-e063-6294a90ac205	2024-07-29	Warnings	Exact identifier application number: M001
Good Neighbor Pharmacy Antacid Regular Strength	CALCIUM CARBONATE	AmerisourceBergen Drug Corporation	2847e82e-203e-4976-8c4f-4a5caa75ce00	2024-07-09	Warnings	Exact identifier application number: M001
Kirkland Ultra Stregth Antacid 171AB	CALCIUM CARBONATE	COSTCO WHOLESALE COMPANY	1bea92e8-1b94-77b0-e063-6394a90a8212	2024-07-08	Warnings	Exact identifier application number: M001
ANTACID AND GASRELIEF	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	GOODSENSE	a951fa64-7775-470e-e053-2995a90aefc4	2024-06-10	Warnings	Exact identifier application number: M001
MINTOX MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	NuCare Pharmaceuticals,Inc.	5b1f4c78-d42e-32c7-e053-2991aa0a1985	2024-06-04	Warnings	Exact identifier application number: M001
Mylanta All-Family Multi Symptom Stomach Remedy	CALCIUM CARBONATE, SIMETHICONE	Infirst Healthcare Inc.	19118884-2016-e86e-e063-6294a90a370c	2024-05-22	Warnings	Exact identifier application number: M001
Stomach Circle K	BISMUTH SUBSALICYLATE	Lil' Drug Store Products, Inc	05e14009-b35d-4711-b6f0-89b6d060b387	2024-05-06	Warnings	Exact identifier application number: M001
Tums Chewy Bites Peppermint	CALCIUM CARBONATE	Haleon US Holdings LLC	45a44b2b-1633-49c5-8c55-9e9af3545c92	2024-05-03	Warnings	Exact identifier application number: M001
MINT ANTACID 100	CALCIUM CARBONATE	JHK Inc dba American Safety & First Aid	2496aed6-68ec-44c4-afc9-f7fa41b2147b	2024-04-24	Warnings	Exact identifier application number: M001
Tums Chewy Bites Assorted Berries	CALCIUM CARBONATE	Navajo Manufacturing Company Inc.	1625c724-7ead-cc70-e063-6294a90aa558	2024-04-15	Warnings	Exact identifier application number: M001
Gas-X Maximum Strength Softgels	SIMETHICONE	Haleon US Holdings LLC	45d1e373-0717-47df-9160-619c451666f4	2024-04-05	Warnings	Exact identifier application number: M001
Gas-X Total Relief Maximum Strength	CALCIUM CARBONATE, SIMETHICONE	Haleon US Holdings LLC	62fc0a91-c44f-4546-a472-c183a2d95486	2024-04-05	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