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 Identifiers#

Field, Values table
FieldValues
Unii3A3U0GI71G
Rxcui198741

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-120-122020-02-11C16284748780-19d75b9d0-bb3f-f424-e053-dadaa90a57ceMagnesium Oxide
58657-120-122020-02-11C16284748780-19d75b9d0-bb3f-f424-e053-dadaa90a57ceMagnesium Oxide
58657-120-122020-01-31C16284748780-19d75b9d0-bb3f-f424-e053-dadaa90a57ceMagnesium Oxide
58657-120-122020-01-31C16284748780-19d75b9d0-bb3f-f424-e053-dadaa90a57ceMagnesium 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

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