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 23 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e0d5be6-d41b-cdf8-e063-6394a90a08b4 2025-02-27 Warnings Exact identifier application number: M001 Supreme Antacid Cherry CALCIUM CARBONATE, MAGNESIUM HYDROXIDE Discount Drug Mart, Inc 2e0a1913-c3d4-7c7d-e063-6294a90a4841 2025-02-26 Warnings Exact identifier application number: M001 Extra Strength sugar free Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2e09f87b-c771-59ae-e063-6294a90a0c39 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Wintergreen Flavor CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 409b5d06-3398-4414-8919-10b9064ba4ee 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Antacid Tropical Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2df92d5c-cd5a-060b-e063-6394a90aa51f 2025-02-25 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Discount Drug Mart, Inc 2e09cb3b-cf5d-15b1-e063-6394a90a5c6a 2025-02-25 Warnings Exact identifier application number: M001 Extra Strength Smooth Assorted Fruit Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df86c35-1e9b-eb49-e063-6294a90aabb6 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Regular strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2dfa0de5-6e58-dc9d-e063-6294a90a53e0 2025-02-20 Warnings Exact identifier application number: M001 Childrens Tummy Relief CALCIUM CARBONATE Genexa Inc. f4d39d3e-82d0-2673-e053-2995a90a7d2a 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Peppermint Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df8fe2b-cc9a-f026-e063-6394a90aa0ad 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb4ce4e-e18c-c96d-e063-6394a90a18ca 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE Harris Teeter, LLC 2cb60b7e-711a-8052-e063-6394a90acf1d 2025-02-20 Warnings Exact identifier application number: M001 Extra Strength Antacid CALCIUM CARBONATE Discount Drug Mart, Inc 2df9e47a-8741-6958-e063-6394a90a6c60 2025-02-20 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Discount Drug Mart, Inc 2e09b8d1-25b4-0e57-e063-6394a90a31e2 2025-02-20 Warnings Exact identifier application number: M001 Tums Chewy Bites Orange and Cream ES CALCIUM CARBONATE Haleon US Holdings LLC 036ef1ed-32ef-46b8-8817-b3f63a014280 2025-02-14 Warnings Exact identifier application number: M001 Tums Naturals CALCIUM CARBONATE Haleon US Holdings LLC d8da54b8-6456-4e7d-acd2-a55e2249bd01 2025-02-13 Warnings Exact identifier application number: M001 Ultra Strength Antacid Assorted Fruit CALCIUM CARBONATE Harris Teeter, LLC 2cb4c58f-ee88-b60e-e063-6294a90a1e6c 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c4fc835-a9ad-2666-e063-6394a90a20ac 2025-02-12 Warnings Exact identifier application number: M001 Maximum Strength Antacid ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE Harris Teeter, LLC 2c5081a6-367f-28bc-e063-6294a90a459e 2025-02-12 Warnings Exact identifier application number: M001 Regular Strength Antacid Peppermint CALCIUM CARBONATE Harris Teeter, LLC 2cb54a40-98ce-2660-e063-6294a90a3ed0 2025-02-11 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