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 7 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mylanta All-Family Multi Symptom Stomach Remedy CALCIUM CARBONATE, SIMETHICONE Sportpharm LLC a70f113d-d5a3-44f5-b223-cd1b0e159e1a 2026-04-24 Warnings Exact identifier application number: M001 Genexa Kids Tummy Relief CALCIUM CARBONATE Genexa Inc. 4f9db9dc-6b78-d123-e063-6294a90ae38d 2026-04-16 Warnings Exact identifier application number: M001 Rugby Extra Strength Antacid CALCIUM CARBONATE Rugby Laboratories c15a5dde-6789-4491-98fd-d248a5c7f076 2026-04-15 Warnings Exact identifier application number: M001 Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Rugby Laboratories bd58baac-5790-455a-9c77-236680992579 2026-04-15 Warnings Exact identifier application number: M001 Rugby Extra Strength Antacid CALCIUM CARBONATE Rugby Laboratories 78f11b4b-d203-45c9-9b29-2c135eb66619 2026-04-15 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr. (650 mg) SODIUM BICARBONATE Gendose Pharmaceuticals, LLC 0a0cc46d-372e-4175-932a-065e82d8d353 2026-04-13 Warnings Exact identifier application number: M001 Extra Strength Antacid Calcium Carbonate, 750mg CALCIUM CARBONATE CHEWABLE TABLETS CVS HEALTH CORP 24cdab48-bcc7-e66f-e063-6394a90abbd7 2026-04-11 Warnings Exact identifier application number: M001 TUMS Smoothies CALCIUM CARBONATE Haleon US Holdings LLC c22944b8-8733-4689-be0c-f320467f79ea 2026-04-01 Warnings Exact identifier application number: M001 Soothe childrens CALCIUM CARBONATE Walgreen Company 0235e083-5f3d-4bae-b14a-b12db623180c 2026-03-31 Warnings Exact identifier application number: M001 Dulcolax Soft Chews Mixed Berry MAGNESIUM HYDROXIDE Chattem, Inc. fe71907c-b1eb-4433-9337-933a944f3e62 2026-03-31 Warnings Exact identifier application number: M001 AMAZON ULTRA STRENGTH ANTACID CALCIUM CARBONATE AMAZON.COM SERVICES LLC 36cf072c-ab61-47de-8fbc-f1d1d981ec84 2026-03-27 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Bryant Ranch Prepack f98cac25-63f2-478e-b785-20cba1c56565 2026-03-27 Warnings Exact identifier application number: M001 Ultra Strength Assorted Fruit Antacid CALCIUM CARBONATE Hyvee Inc 44eaa023-0f11-1256-e063-6394a90a4167 2026-03-26 Warnings Exact identifier application number: M001 Rapidol Sodium Bicarbonate SODIUM BICARBONATE Pharmadel LLC b4c9a653-6f51-7c98-e053-2995a90ada37 2026-03-26 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE Grocery Outlet, Inc. 4465441f-c518-8c1d-e063-6294a90a7407 2026-03-25 Warnings Exact identifier application number: M001 Ultra Strength Assorted Berry Antacid CALCIUM CARBONATE Hyvee Inc 44ea74ce-2b9f-e578-e063-6394a90ab72d 2026-03-25 Warnings Exact identifier application number: M001 Antacid Melts CALCIUM CARBONATE 250MG Quest Products, LLC 4dcc5323-eafe-0dc8-e063-6294a90acb60 2026-03-24 Warnings Exact identifier application number: M001 Sodium Bicarbonate Antacid SODIUM BICARBONATE Aphena Pharma Solutions - Tennessee, LLC bba7d5bf-c94b-4ee4-a399-9a2818d84c78 2026-03-23 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Grocery Outlet, Inc. 44657e4a-6093-bcab-e063-6394a90a4837 2026-03-19 Warnings Exact identifier application number: M001 Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch CALCIUM CARBONATE AND SIMETHICONE Bayer HealthCare LLC. 41d17406-3653-4889-81df-6270b7b5d3c7 2026-03-12 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