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 14 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Ultra Stregth Antacid CALCIUM CARBONATE Wal-Mart Stores, Inc. cdfe5c95-3f90-4620-a618-18bac0471c3e 2025-12-03 Warnings Exact identifier application number: M001 Walgreens Fast Acting Heartburn Relief Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE WALGREEN CO. 6eae97f3-a174-4cbc-badc-777475d2f7af 2025-11-26 Warnings Exact identifier application number: M001 Antacid Regular Strength ANTACID WALGREEN CO. ce5eef7f-497d-4c88-be6a-17eeb6e07f5b 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID WALGREEN CO. 2981c5f7-121a-4030-86b1-559061030e7a 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID CALCIUM CARBONATE WALGREEN CO. 14baa410-6ce3-4ddb-aac7-e2172d1506c4 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength ANTACID WALGREEN CO. aa797e94-6560-41c9-8c71-458a1086e841 2025-11-25 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE WALGREEN COMPANY d66ec376-9cac-4de5-aac8-7c6f9aa210ce 2025-11-25 Warnings Exact identifier application number: M001 Antacid Extra Strength Wintergreen ANTACID WALGREEN CO. ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength ANTACID WALGREEN CO. 09ef90c3-1fc3-48be-8071-2fa387a46175 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength Assorted Fruits ANTACID WALGREEN CO. 6d6cecdc-646b-4c7b-b325-9423c29c57fc 2025-11-25 Warnings Exact identifier application number: M001 Antacid Ultra Strength Assorted Fruits ANTACID WALGREEN CO. e1b55f3a-c6d7-4374-acc7-134786a3765e 2025-11-25 Warnings Exact identifier application number: M001 ULTRA STRENGTH Antacid CALCIUM CARBONATE WALGREEN CO a4dcf7b9-d2c3-45d3-9410-fc4d55052a3c 2025-11-25 Warnings Exact identifier application number: M001 FAST ACTING Heartburn Relief ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE WALGREEN CO. 48c14005-811a-4868-b33e-934845504856 2025-11-25 Warnings Exact identifier application number: M001 Walgreens Childrens Saline Laxative MAGNESIUM HYDROXIDE WALGREEN CO. 3813ed22-cf68-4c16-9b61-c39828120079 2025-11-25 Warnings Exact identifier application number: M001 Ultra Strength Assorted Berries CALCIUM CARBONATE SAM'S WEST INC bc619258-7451-460c-9472-95678ea82d6e 2025-11-20 Warnings Exact identifier application number: M001 Gelusil ALUMINA, MAGNESIA, SIMETHICONE WellSpring Pharmaceutical Corporation 92fbeec1-1562-40f3-9734-41f133d494f9 2025-11-20 Warnings Exact identifier application number: M001 GERI-MOX ANTACID ANTIGAS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE Geri-Care Pharmaceuticals, Corp 03358bc7-8819-4a05-bc13-27fbf486bd26 2025-11-20 Warnings Exact identifier application number: M001 Melox ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Belmora LLC d41f0b26-5add-4045-9754-37d70d120d28 2025-11-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Vanilla and Mint CALCIUM CARBONATE Haleon US Holdings LLC 2b9dd909-c850-3c21-e063-6394a90a15a8 2025-11-19 Warnings Exact identifier application number: M001 MAXIMUM STRENGTH ANTACID ANTIGAS ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE WALGREEN COMPANY 7cd8fdf4-f762-f936-e053-2a91aa0aa6ee 2025-11-19 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