FDA.reportPublic FDA data

Mag 440

Product NDC
28595-710
11-digit product format
285950710
Labeler code
28595
Product ID
28595-710_32fd7e5e-f1bd-85e9-e063-6294a90a876f
Type
HUMAN OTC DRUG
Nonproprietary name
Megnesium Oxide
Dosage form
TABLET
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-27
Substance
MAGNESIUM OXIDE
Active strength
440 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

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
Mag 440
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM OXIDE440 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
2707337Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cb19dc0-115b-38b8-e063-6294a90a4aeaAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-710-40Mag 44040 in 1 BOTTLETABLET403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-710-40EA - Each28595-710c2d507f7-8b42-44e0-8691-9847fb9a806412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-710MAG 440 (MEGNESIUM OXIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20250418_2cb19dc0-115b-38b8-e063-6294a90a4aea.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 15 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Childrens Saline LaxativeMAGNESIUM HYDROXIDEWALGREEN CO.3813ed22-cf68-4c16-9b61-c398281200792025-11-25WarningsExact identifier
application number: M001
Ultra Strength Assorted BerriesCALCIUM CARBONATESAM'S WEST INCbc619258-7451-460c-9472-95678ea82d6e2025-11-20WarningsExact identifier
application number: M001
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
application number: M001
GERI-MOX ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp03358bc7-8819-4a05-bc13-27fbf486bd262025-11-20WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCd41f0b26-5add-4045-9754-37d70d120d282025-11-20WarningsExact identifier
application number: M001
Tums Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5e996df3-25a4-b259-e053-2a91aa0a43112025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND GAS RELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERITE AID PHARMACY6014342d-ad46-ae71-e053-2991aa0a89292025-11-19WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpa7d7298f-44d6-4e09-8578-7fe3112430022025-11-19WarningsExact identifier
application number: M001
GERI-MOX MAX CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp8e57bcf5-2960-4c41-8bf2-83cb1ee501682025-11-19WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGR J General Corporation6208d11d-0670-4a20-a3fc-ebc764a8e6cd2025-11-17WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
application number: M001
Antacid ChildrensCALCIUM CARBONATECVS Pharmacy08953df1-cc29-452f-bc69-b19970a1fd2e2025-11-15WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc0bb322a5-fb92-14de-e063-6294a90a4c1b2025-11-14WarningsExact identifier
application number: M001
magnesium oxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc.dc57893c-068a-37d8-e053-2a95a90aa0542025-11-14WarningsExact identifier
application number: M001
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
application number: M001
Topcare Antacid Extra Strength Assorted BerryCALCIUM CARBONATETopco Associates LLC14f6f475-32d6-4783-8dcc-1fe265902d552025-11-10WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC38c26f49-fb5e-480c-9164-bf5edcf0726b2025-11-10WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707337magnesium oxide 440 MG Oral TabletPSN2cb19dc0-115b-38b8-e063-6294a90a4aea3
2707337magnesium oxide 440 MG Oral TabletSCD2cb19dc0-115b-38b8-e063-6294a90a4aea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
28595-710-402859507104040 TABLET in 1 BOTTLE (28595-710-40) 40 tablet2025-01-27NoNoCurrent