FDA.reportPublic FDA data

Magnesium Oxide

Product NDC
81033-027
11-digit product format
810330027
Labeler code
81033
Product ID
81033-027_4225e628-15ad-6bf0-e063-6394a90a98d6
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Oxide
Dosage form
TABLET
Route
ORAL
Labeler
Kesin Pharma
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-07
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

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
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
31f417f0-1637-eefa-e063-6294a90a121bAvailable 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
81033-027-01Magnesium Oxide10 in 1 CARTONTABLET102
81033-027-12Magnesium Oxide120 in 1 BOTTLETABLET1202
81033-027-41Magnesium Oxide100 in 1 BLISTER PACKTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-027-01EA - Each81033-02719739058-48c9-4d88-9671-511f131bff1b12026-05-22
81033-027-12EA - Each81033-027782cadc8-b6c0-44a0-9b3f-1278a3d24d1d12025-10-14
81033-027-41EA - Each81033-027e07bdfca-b7b4-4057-a0c3-a192951d59cb12026-05-22

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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids Ultra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.8806c912-ab83-4f45-ac78-e826bb3143d42026-01-14WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Wild BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.07649a83-0123-4bb5-b130-3067c7d052c52026-01-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e1a46c-5665-ac4c-e063-6294a90a9b812026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e19b30-3784-ad98-e063-6294a90aa5662026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEMedical Group Care LLC47e1bc32-baf5-ad9a-e063-6294a90ad5b42026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC47e1c7c7-4f3b-c04b-e063-6394a90a775f2026-01-08WarningsExact identifier
application number: M001
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
application number: M001
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
application number: M001
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
application number: M001
QC Ultra Strength Antacid Soft Chews, CherryQC ANTACID SOFT CHEWS, CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a97517-d3e7-d896-e063-6394a90acc952025-12-29WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATESelect Consumer Group3caa037e-3424-f9ce-e063-6294a90ac1e82025-12-27WarningsExact identifier
application number: M001
AntacidANTACIDXiamen Kang Zhongyuan Biotechnology Co., Ltd.17adb983-bb28-bf8b-e063-6394a90a7daa2025-12-26WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198741magnesium oxide 400 MG Oral TabletPSN31f417f0-1637-eefa-e063-6294a90a121b2
198741magnesium oxide 400 MG Oral TabletSCD31f417f0-1637-eefa-e063-6294a90a121b2
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY31f417f0-1637-eefa-e063-6294a90a121b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-027-018103300270110 BLISTER PACK in 1 CARTON (81033-027-01) / 100 TABLET in 1 BLISTER PACK (81033-027-41) 10 blister pack2025-11-01NoNoCurrent
81033-027-1281033002712120 TABLET in 1 BOTTLE (81033-027-12) 120 tablet2025-04-07NoNoCurrent
81033-027-4181033002741100 in 1 BLISTER PACKHistorical