FDA.reportPublic FDA data

Magnesium Oxide

Product NDC
58657-120
11-digit product format
586570120
Labeler code
58657
Product ID
58657-120_41b54dc8-16af-7ea0-e063-6394a90ad7b2
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Oxide
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-25
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

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM OXIDE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3A3U0GI71GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0af63651-f9d9-43b9-b6f0-4878466a82e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-11Magnesium Oxide
2020-02-11Magnesium Oxide
2020-01-31Magnesium Oxide
2020-01-31Magnesium Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-120-12Magnesium Oxide120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-120-12EA - Each58657-120dccb36af-6ab1-4ff2-8c9a-629be7f1e7c812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-120MAGNESIUM OXIDE TABLET [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 1 package rows20241126_0af63651-f9d9-43b9-b6f0-4878466a82e6.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 · 747 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
application number: M001
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
application number: M001
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
application number: M001
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
application number: M001
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEDOLGENCORP, LLC98a0503c-add5-4453-9d9d-6f813866f4b32026-09-03WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC4942747a-8b6c-422a-8150-9bd91c0a37782026-09-03WarningsExact identifier
application number: M001
DG HEALTH Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLC13dd2758-a372-4b0e-bc99-56a2dacbf95f2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Antacid Wintergreen flavorCALCIUM CARBONATEDOLGENCORP, LLCb84b3509-3178-4616-9bec-dad85a4f9d2a2026-09-03WarningsExact identifier
application number: M001
DG Health Regular Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC59ad3cc7-4144-442f-a37d-75c5fe23e1ae2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Assorted Fruits AntacidCALCIUM CARBONATEDOLGENCORP, LLC112f1002-c007-4363-ade6-8dfbc61f4b642026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidSMOOTH DISSOLVE CALCIUM CARBONATEDOLGENCORP, LLCcabaa8f7-9c93-439d-905a-5ef643a08ea82026-09-03WarningsExact identifier
application number: M001
Kroger Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETHE KROGER CO.,175d9f0f-266a-4dc2-865f-d1ebd4ddac512026-09-01WarningsExact identifier
application number: M001
Kids AntacidCALCIUM CARBONATETHE KROGER CO.d77c629b-5308-4b71-9024-9899cf88dbae2026-09-01WarningsExact identifier
application number: M001
Kroger Extra Strength Smooth Antacid Assorted BerryCALCIUM CARBONATEKROGER COMPANY4c8d39d9-9d58-45df-9ffd-2cdc41539c032026-09-01WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198741magnesium oxide 400 MG Oral TabletPSN77fa8fe5-33ac-44b2-9596-5b276e9f2162105
198741magnesium oxide 400 MG Oral TabletSCD77fa8fe5-33ac-44b2-9596-5b276e9f2162105
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY77fa8fe5-33ac-44b2-9596-5b276e9f2162105
198741magnesium oxide 400 MG Oral TabletPSN3aba26ec-5ebe-433e-9524-fb355c5a0198104
198741magnesium oxide 400 MG Oral TabletSCD3aba26ec-5ebe-433e-9524-fb355c5a0198104
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY3aba26ec-5ebe-433e-9524-fb355c5a0198104
198741magnesium oxide 400 MG Oral TabletPSN9875ae6b-2d91-49a3-9512-60a2b8bbccda103
198741magnesium oxide 400 MG Oral TabletSCD9875ae6b-2d91-49a3-9512-60a2b8bbccda103
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY9875ae6b-2d91-49a3-9512-60a2b8bbccda103
198741magnesium oxide 400 MG Oral TabletPSNf98cac25-63f2-478e-b785-20cba1c56565101
198741magnesium oxide 400 MG Oral TabletSCDf98cac25-63f2-478e-b785-20cba1c56565101
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSYf98cac25-63f2-478e-b785-20cba1c56565101
198741magnesium oxide 400 MG Oral TabletPSN0af63651-f9d9-43b9-b6f0-4878466a82e67
198741magnesium oxide 400 MG Oral TabletSCD0af63651-f9d9-43b9-b6f0-4878466a82e67
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY0af63651-f9d9-43b9-b6f0-4878466a82e67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-120-1258657012012120 TABLET in 1 BOTTLE (58657-120-12) 120 tablet2018-07-250000-00-00NoNoCurrent