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 1 of 36 · 719 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Stomach Relief CALCIUM CARBONATE Wal-Mart Stores Inc 7471ec99-6c0b-40d8-a9cf-85240a0d471a 2026-09-09 Warnings Exact identifier application number: M001 Walgreens Orange Antacid Soft Chew CALCIUM CARBONATE Walgreens 5b01be31-5871-d4f5-e063-6294a90a671a 2026-09-08 Warnings Exact identifier application number: M001 Regular Strength Tropical Fruit CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 38c6cece-71a0-40d8-bfc8-2f6467f9239b 2026-09-05 Warnings Exact identifier application number: M001 Extra Strength Antacid Assorted Berries CALCIUM CARBONATE RARITAN PHARMACEUTICALS INC 07a50168-6b05-4c99-9969-7d7f0aa54f30 2026-09-05 Warnings Exact identifier application number: M001 DRx CHOICE Antacid Calcium Regular Strength CALCIUM CARBONATE 500MG Raritan Pharmaceuticals Inc 0c579405-9397-4bf2-8441-e89011b19ec4 2026-09-05 Warnings Exact identifier application number: M001 Tums Chewy Bites Wintermint and Vanilla Cream CALCIUM CARBONATE Haleon US Holdings LLC 4f094feb-8de1-4ccb-e063-6294a90acec2 2026-09-04 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE DOLGENCORP, LLC 98a0503c-add5-4453-9d9d-6f813866f4b3 2026-09-03 Warnings Exact identifier application number: M001 DG health Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE DOLGENCORP, LLC 99c7ab95-df12-4041-ae1a-398cc6f0085d 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Ultra Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Liquid Antacid plus Anti Gas CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE DOLGENCORP, LLC 8ecb4418-e647-49b5-b418-1c63bb3e5a3c 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 4942747a-8b6c-422a-8150-9bd91c0a3778 2026-09-03 Warnings Exact identifier application number: M001 DG HEALTH Regular Strength ANTACID TABLETS (CALCIUM CARBONATE) DOLGENCORP, LLC 13dd2758-a372-4b0e-bc99-56a2dacbf95f 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid Wintergreen flavor CALCIUM CARBONATE DOLGENCORP, LLC b84b3509-3178-4616-9bec-dad85a4f9d2a 2026-09-03 Warnings Exact identifier application number: M001 DG Health Regular Strength Antacid CALCIUM CARBONATE DOLGENCORP, LLC 59ad3cc7-4144-442f-a37d-75c5fe23e1ae 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Assorted Fruits Antacid CALCIUM CARBONATE DOLGENCORP, LLC 112f1002-c007-4363-ade6-8dfbc61f4b64 2026-09-03 Warnings Exact identifier application number: M001 DG health Extra Strength Antacid SMOOTH DISSOLVE CALCIUM CARBONATE DOLGENCORP, LLC cabaa8f7-9c93-439d-905a-5ef643a08ea8 2026-09-03 Warnings Exact identifier application number: M001 Kroger Extra Strength ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE THE KROGER CO., 175d9f0f-266a-4dc2-865f-d1ebd4ddac51 2026-09-01 Warnings Exact identifier application number: M001 Kids Antacid CALCIUM CARBONATE THE KROGER CO. d77c629b-5308-4b71-9024-9899cf88dbae 2026-09-01 Warnings Exact identifier application number: M001 Kroger Extra Strength Smooth Antacid Assorted Berry CALCIUM CARBONATE KROGER COMPANY 4c8d39d9-9d58-45df-9ffd-2cdc41539c03 2026-09-01 Warnings Exact identifier application number: M001 Kroger Ultra Strength Assorted Fruit CALCIUM CARBONATE KROGER COMPANY b60ced06-725c-4dae-abbf-21cab9e431f9 2026-08-31 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