Home NDC 0603-0209 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…
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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 17 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Strength CALCIUM CARBONATE BETTER LIVING BRANDS LLC 3ff92c9a-987f-468e-9e18-1e3e171ede14 2025-10-29 Warnings Exact identifier application number: M001 Ultra Strength CALCIUM CARBONATE BETTER LIVING BRANDS LLC 35b3d9d0-b04d-4f6d-b99d-435233803d4b 2025-10-29 Warnings Exact identifier application number: M001 Ultra Strength ANTACID TABLETS SAFEWAY 4c6cdd81-5145-4a1f-888f-85cf5d856c39 2025-10-29 Warnings Exact identifier application number: M001 Extra Strength Smooth ANTACID TABLETS SAFEWAY 8ed35c3b-9878-4889-90f7-a3973cf806e0 2025-10-29 Warnings Exact identifier application number: M001 Publix Regular Strength Assorted Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC fd637431-7a08-4454-9cae-a68716d2d0fa 2025-10-28 Warnings Exact identifier application number: M001 Publix Regular Strength Peppermint Flavor CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC c41b6cc2-c852-45fd-858c-c7bedc5dc882 2025-10-28 Warnings Exact identifier application number: M001 Publix Extra Strength Assorted Berry CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC a270fc36-f2b2-4f56-81d4-cf165f6b5abe 2025-10-28 Warnings Exact identifier application number: M001 Extra Strength Sugar Free Orange Cream Flavor CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 4dbdabc4-280d-4c9a-8c54-84afc615c8c7 2025-10-28 Warnings Exact identifier application number: M001 Publix Extra Strength Tropical Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 28e8dd03-25cf-43db-8c4d-3aae99be9d53 2025-10-28 Warnings Exact identifier application number: M001 Publix Ultra Strength Assorted Fruit CALCIUM CARBONATE PUBLIX SUPER MARKETS, INC 9e1c883f-016e-4c05-b27a-750d14c0f3e5 2025-10-28 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., 48827658-02f7-4599-a90a-1543b30b9de1 2025-10-27 Warnings Exact identifier application number: M001 Regular Strength Antacid ANTACID Wal-Mart Stores,Inc., 6e7cd170-b169-4fc0-bc90-f4421bbd9fcd 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., febe9d70-9a1f-43a9-8ad0-3134eefc6967 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc., d399f927-e80b-4162-a1f1-ef6159d6f7b1 2025-10-27 Warnings Exact identifier application number: M001 equate Sugar Free Extra Strength Antacid Orange Cream Flavor ANTACID Wal-Mart Stores,Inc., 53a22b37-66af-4735-b262-15e06ad7bf76 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid CALCIUM CARBONATE Wal-Mart Stores,Inc. 841ddf88-a016-4a3c-9508-5d5702883d8f 2025-10-27 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Wal-Mart Stores,Inc., 6900fabc-2299-48cf-bbda-c92649cfd0e1 2025-10-27 Warnings Exact identifier application number: M001 equate Ultra Strength Antacid Peppermint Flavor ANTACID TABLETS Wal-Mart Stores,Inc., 6a18cd92-cc51-401b-9074-fbaa1afb42ac 2025-10-27 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid ANTACID TABLETS Wal-Mart Stores,Inc., 9acdfb08-043d-48a5-95f9-54bcba733c6e 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Antacid ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Wal-Mart Stores,Inc 448d1c72-2308-4041-8ba6-dd1e0802cc47 2025-10-27 Warnings Exact identifier application number: M001
DailyMed RxNorm Mappings# 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