Magnesium Oxide

Product NDC: 54738-973
11-digit product format: 547380973
Labeler code: 54738
Product ID: 54738-973_2a329845-3f50-540c-e063-6394a90af0a9
Type: HUMAN OTC DRUG
Nonproprietary name: Magnesium Oxide
Dosage form: TABLET
Route: ORAL
Labeler: Richmond Pharmaceuticals, Inc.
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-02-01
Substance: MAGNESIUM OXIDE
Active strength: 400 mg/1
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54738-973		D	Discontinued by firm		2026-10-12
excluded package	package	54738-973	54738-973-12	D	Discontinued by firm		2026-10-12

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54738-973-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54738-973-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54738-973-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54738-973-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54738-973-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54738-973-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54738-973-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54738-973-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54738-973-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54738-973-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54738-973-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54738-973-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Magnesium Oxide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAGNESIUM OXIDE	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3A3U0GI71G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198741	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9119b7f0-3e8a-7be7-e053-2995a90a4634	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54738-973-12	Magnesium Oxide	120 in 1 BOTTLE	TABLET	120		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54738-973-12	EA - Each	54738-973	cda5701d-ab64-44dd-ae6a-54bd03c6e7fa	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54738-973	MAGNESIUM OXIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 1 package rows	20241228_9119b7f0-3e8a-7be7-e053-2995a90a4634.zip

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 2 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Extra Strength Sugar Free	CALCIUM CARBONATE	KROGER COMPANY	3f737ce2-961e-4bd0-ae6d-078248cf1c67	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Extra Strength Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	fa191237-d230-4528-8dff-50e8d5c65b6d	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Ultra Strength Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	b7db77a7-0580-455b-a2ef-a68584f03981	2026-08-31	Warnings	Exact identifier application number: M001
Ultra Strength Natural Antacid	CALCIUM CARBONATE	KROGER COMPANY	2931d427-b2be-4db9-a58d-ff89c221ff51	2026-08-31	Warnings	Exact identifier application number: M001
Ultra Strength Antacid	ANTACID TABLETS	THE KROGER CO.,	f5d82d1b-2f75-4af4-8337-a5bd28c26fb7	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Extra Strength Assorted Fruit	CALCIUM CARBONATE	KROGER COMPANY	486d7a5f-cbc8-4f86-b12e-c5325bd8c62d	2026-08-31	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Preferred Pharmaceuticals Inc.	3b049027-30ac-4c78-a4f1-8191f7ed45bf	2026-08-27	Warnings	Exact identifier application number: M001
Extra Strength Gas Relief	SIMETHICONE	Shield Pharmaceuticals Corp	534144be-fcaf-400d-b772-595c62ae6ea6	2026-08-27	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Guardian Drug Company	48ec50ab-f24b-367b-e063-6294a90ad736	2026-08-27	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	KROGER COMPANY	b9e61a03-e008-50ab-e053-2a95a90a3210	2026-08-26	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS PHARMACY	af71e02d-e7c7-f925-e053-2995a90a0861	2026-08-26	Warnings	Exact identifier application number: M001
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M001
Dr. Sana Lemon Alivio Digestivo UPSET STOMACH	EFFERVESCENT ANTACID	EVI LABS	59cdf417-e5c0-6bb2-e063-6294a90a9c51	2026-08-24	Warnings	Exact identifier application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACH	EFFERVESCENT ANTACID	EVI LABS	59d07c2d-ef11-bd32-e063-6394a90af87d	2026-08-24	Warnings	Exact identifier application number: M001
Genexa Antacid Maximum Strength	CALCIUM CARBONATE	Genexa Inc.	3a39d91c-2dcd-71d6-e063-6394a90a5474	2026-08-22	Warnings	Exact identifier application number: M001
Mag-AL Plus	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	PAI Holdings, LLC dba PAI Pharma	896ab07a-1b40-43ab-8589-3be86b1c4198	2026-08-19	Warnings	Exact identifier application number: M001
CVS Health Extra Strength Antacid	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	CVS PHARMACY	8629529e-4363-4d37-9ae0-27193868df32	2026-08-19	Warnings	Exact identifier application number: M001
Mylanta Fall Harvest Collection Spiced Apple Cider	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	5a6040ff-1779-3215-e063-6294a90aaab1	2026-08-15	Warnings	Exact identifier application number: M001
Mylanta Fall Harvest Collection Pumpkin Spice	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	5a60a221-5b37-806e-e063-6394a90a5ccc	2026-08-15	Warnings	Exact identifier application number: M001
CVS Naturals	CALCIUM CARBONATE	CVS PHARMACY	899f057a-914d-49ca-a9fd-9fc48149782a	2026-08-14	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3A3U0GI71G	MAGNESIUM OXIDE	1309-48-4	MAGNESIUM OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198741	magnesium oxide 400 MG Oral Tablet	PSN	9119b7f0-3e8a-7be7-e053-2995a90a4634	13
198741	magnesium oxide 400 MG Oral Tablet	SCD	9119b7f0-3e8a-7be7-e053-2995a90a4634	13
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	9119b7f0-3e8a-7be7-e053-2995a90a4634	13
198741	magnesium oxide 400 MG Oral Tablet	PSN	edabc9e4-60ad-407f-97c8-dfec5ee7eeb1	1
198741	magnesium oxide 400 MG Oral Tablet	SCD	edabc9e4-60ad-407f-97c8-dfec5ee7eeb1	1
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	edabc9e4-60ad-407f-97c8-dfec5ee7eeb1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54738-973-12	54738097312	120 TABLET in 1 BOTTLE (54738-973-12)	120 tablet	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Magnesium Oxide Tablets	Richmond Pharmaceuticals, Inc. \| Advance Pharmaceutical, Inc.	2024-12-26	HUMAN OTC DRUG LABEL	13
Magnesium Oxide Tablets	Aphena Pharma Solutions - Tennessee, LLC	2018-10-25	HUMAN OTC DRUG LABEL	1