Magnesium Oxide

Product NDC: 0603-0209
11-digit product format: 006030209
Labeler code: 0603
Product ID: 0603-0209_f385cf62-d6c3-4072-a788-831e05f98638
Type: HUMAN OTC DRUG
Nonproprietary name: Magnesium Oxide
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-07-01
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

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 · 4 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
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	0603-0209-22	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	0603-0209-22	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
d3c5b01b-f0d6-4503-ab18-b1a72386e2c6	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0603-0209-22	2020-10-16	C162847	48780-1	9d75b9d0-d70b-f424-e053-dadaa90a57ce	Magnesium Oxide Tablets
0603-0209-22	2020-01-31	C162847	48780-1	9d75b9d0-d70b-f424-e053-dadaa90a57ce	Magnesium Oxide Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0603-0209-22	Magnesium Oxide	120 in 1 BOTTLE	TABLET	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-0209-22	EA - Each	0603-0209	de9bb288-5b61-49a3-918e-60f3a72fa693	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MAGNESIUM OXIDE	ACTIVE INGREDIENT	3A3U0GI71G	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
MAGNESIUM OXIDE	ACTIVE INGREDIENT	3A3U0GI71G	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM OXIDE	ACTIVE INGREDIENT	3A3U0GI71G	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM OXIDE	ACTIVE INGREDIENT	3A3U0GI71G	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MAGNESIUM OXIDE TABLET [SAFECOR HEALTH, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MAGNESIUM OXIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-0209	MAGNESIUM OXIDE TABLET [ENDO USA]	10	Current NDC, Legacy NDC, 1 package rows	20241108_d3c5b01b-f0d6-4503-ab18-b1a72386e2c6.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 1 of 38 · 742 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Bicarbonate 5 gr	SODIUM BICARBONATE	TWIN MED LLC	e325d899-d9a6-5adb-e053-2995a90ac861	2026-08-04	Warnings	Exact identifier application number: M001
LYOPHILIZED AMNION WITH ALBUMIN	HUMAN AMNIOTIC MEMBRANE	Guangzhou Yilong Cosmetics.,Ltd	57c5a5a5-bbd1-27c3-e063-6294a90a7453	2026-08-02	Warnings	Exact identifier application number: M001
TUMS ULTRA	CALCIUM CARBONATE	Haleon US Holdings LLC	348d3dfa-6a52-4583-96e3-83c4bf2df45b	2026-07-27	Warnings	Exact identifier application number: M001
Extra Strength Assorted Berry	CALCIUM CARBONATE	BJWC	bc56a82e-b875-4a4c-9b49-4bfbc6918724	2026-07-22	Warnings	Exact identifier application number: M001
Best Choice Ultra Strength	ANTACID TABLETS (CALCIUM CARBONATE)	BEST CHOICE (VALU MERCHANDISERS COMPANY)	1547b549-efd0-46da-8f91-3d7e4d4a2f3a	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Extra Strength Berry Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	529d7da6-5997-41f5-bfb8-33d2bbdce78e	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Extra Strength Tropical Fruit	CALCIUM CARBONATE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	09e25e8e-a861-45cb-a919-36c30d3b7f7b	2026-07-17	Warnings	Exact identifier application number: M001
LEADER ULTRA STRENGTH	ANTACID CALCIUM CARBONATE	CARDINAL HEALTH 110, LLC. DBA LEADER	713c74bf-f586-4c63-82aa-5ed3a611d7a0	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Regular Strength	CALCIUM CARBONATE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd	2026-07-17	Warnings	Exact identifier application number: M001
Fast Acting Heartburn Relief Peppermint Flavor	CALCIUM CARBONATE	Raritan Pharmaceuticals Inc	a7c5a5db-bdfe-4601-ae51-dedd81626b0d	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Extra Strength	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	1989551d-b977-4d5e-8b01-153cd9d638fc	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Extra Strength Assorted Berry	CALCIUM CARBONATE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	412a5be3-2f90-483c-8169-b733861f3aa1	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Assorted Fruit	CALCIUM CARBONATE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	cd9e2e11-25a8-4096-870a-9d0269e6c7a9	2026-07-17	Warnings	Exact identifier application number: M001
Best Choice Extra Strength	SMOOTH ANTACID TABLETS	BEST CHOICE (VALU MERCHANDISERS COMPANY)	c5141eb9-d851-453e-b51c-f436a647495a	2026-07-17	Warnings	Exact identifier application number: M001
Gelfos-M	ALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONE	Masaem Company	56b9a769-08fb-738f-e063-6294a90a9eb2	2026-07-16	Warnings	Exact identifier application number: M001
Extra Strength Gas Relief	SIMETHICONE	Shield Pharmaceuticals Corp	e62f6f6f-59a9-4df4-91ca-a76c4de93fe0	2026-07-15	Warnings	Exact identifier application number: M001
Simethicone	TARGET BERRY BLAST ANTACID HBG CHEW	Target	5245af45-77c7-c95f-e063-6294a90a24f7	2026-07-15	Warnings	Exact identifier application number: M001
Amazon Basics Cherry Antacid SC	CALCIUM CARBONATE	Amazon	4b1d6e4e-8b59-ec06-e063-6394a90aa60d	2026-07-15	Warnings	Exact identifier application number: M001
FEVIA Acid Control	CALCIUM CARBONATE	VIVUNT PHARMA LLC	4b1bd2d1-c909-f5db-e063-6394a90a84bc	2026-07-15	Warnings	Exact identifier application number: M001
FEVIA Acid Control	CALCIUM CARBONATE	VIVUNT PHARMA LLC	4d695a90-6502-3020-e063-6394a90ab0c3	2026-07-15	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	d3c5b01b-f0d6-4503-ab18-b1a72386e2c6	10
198741	magnesium oxide 400 MG Oral Tablet	SCD	d3c5b01b-f0d6-4503-ab18-b1a72386e2c6	10
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	d3c5b01b-f0d6-4503-ab18-b1a72386e2c6	10
198741	magnesium oxide 400 MG Oral Tablet	PSN	0847c51f-a759-46ac-b881-d47e2f407818	1
198741	magnesium oxide 400 MG Oral Tablet	PSN	11b2ce71-61fd-4e75-a859-a260b1dda080	1
198741	magnesium oxide 400 MG Oral Tablet	PSN	b9d11379-a86d-4cc5-bbe4-8444db7bce5a	1
198741	magnesium oxide 400 MG Oral Tablet	SCD	0847c51f-a759-46ac-b881-d47e2f407818	1
198741	magnesium oxide 400 MG Oral Tablet	SCD	11b2ce71-61fd-4e75-a859-a260b1dda080	1
198741	magnesium oxide 400 MG Oral Tablet	SCD	b9d11379-a86d-4cc5-bbe4-8444db7bce5a	1
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	0847c51f-a759-46ac-b881-d47e2f407818	1
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	11b2ce71-61fd-4e75-a859-a260b1dda080	1
198741	magnesium oxide 400 MG (magnesium 241.3 MG) Oral Tablet	SY	b9d11379-a86d-4cc5-bbe4-8444db7bce5a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-0209-22	00603020922	120 TABLET in 1 BOTTLE (0603-0209-22)	120 tablet	2014-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Magnesium Oxide Tablets	Endo USA	2020-06-03	HUMAN OTC DRUG LABEL	10
Magnesium Oxide Tablets	Aphena Pharma Solutions - Tennessee, LLC	2018-11-07	HUMAN OTC DRUG LABEL	1
Magnesium Oxide Tablets	State of Florida DOH Central Pharmacy	2013-09-25	HUMAN OTC DRUG LABEL	1
Magnesium Oxide Tablets	Physicians Total Care, Inc.	2012-09-18	HUMAN OTC DRUG LABEL	1
Magnesium Oxide Tablets	Safecor Health, LLC	2012-07-16	HUMAN OTC DRUG LABEL	1