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 18 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Smooth Antacid ANTACID TABLETS Wal-Mart Stores,Inc., 92372491-000d-4273-a668-b87722c1d381 2025-10-27 Warnings Exact identifier application number: M001 equate Extra Strength Smooth Antacid Assorted Berries ANTACID TABLETS Wal-Mart Stores,Inc., cc93e3b4-adbc-4a2c-b6fc-bf7456ef1656 2025-10-27 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Kesin Pharma 31f417f0-1637-eefa-e063-6294a90a121b 2025-10-27 Warnings Exact identifier application number: M001 Rugby Extra Strength Assorted Berries ANTACID TABLETS Rugby Laboratories b0fcfd66-276e-4741-9aee-915b6364f25c 2025-10-25 Warnings Exact identifier application number: M001 Rugby ANTACID TABLETS Rugby Laboratories 9cb56bc3-7075-4f81-bd10-7e602034b7d8 2025-10-25 Warnings Exact identifier application number: M001 Rugby Cal-Gest Antacid Assorted Flavors ANTACID TABLETS Rugby Laboratories, Inc. a43184c4-d225-4539-b651-4d96535f208f 2025-10-25 Warnings Exact identifier application number: M001 Super vitamin C serum SUPER VITAMIN C FlexiGo Inc 41cbe84e-3ddf-b806-e063-6294a90a55a4 2025-10-22 Warnings Exact identifier application number: M001 Exchange Select Antacid Soft Chews Cherry Flavor CALCIUM CARBONATE Army & Air Force Exchange Service 41ad5581-5b8a-1c8b-e063-6294a90a2ba6 2025-10-21 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE Method Pharmaceuticals, LLC 0af63651-f9d9-43b9-b6f0-4878466a82e6 2025-10-21 Warnings Exact identifier application number: M001 CardinalExtra Strength Antacid Wintergreen flavor CALCIUM CARBONATE CARDINAL HEALTH 4e40989f-c710-442a-bb8d-02e813ddf04d 2025-10-14 Warnings Exact identifier application number: M001 Regular Strength Antacid Assorted Fruit CALCIUM CARBONATE CARDINAL HEALTH def9eaef-308f-49f2-898b-469c2c395d27 2025-10-14 Warnings Exact identifier application number: M001 Leader Extra Strength Sugar Free Antacid ANTACID Cardinal Health d7a6f1b8-bdf7-45bb-bab0-b22f45e78440 2025-10-14 Warnings Exact identifier application number: M001 Extra Strength Antacid Original Flavor ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Cardinal Health 1fe459f6-be7f-4c59-b33b-f13ec17071f2 2025-10-14 Warnings Exact identifier application number: M001 Cardinal Extra Strength Smooth Antacid Assorted Fruits CALCIUM CARBONATE CARDINAL HEALTH 84bf7fea-a071-4583-9453-1aea4d198ca6 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE Cardinal Health 110, LLC. 3ce9b97b-1680-4299-9a2c-132318adbc0c 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Extra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. 7c1b2ee6-b691-4c12-bed5-f0a360ad46bb 2025-10-14 Warnings Exact identifier application number: M001 ANTACID Ultra Strength CALCIUM CARBONATE CARDINAL HEALTH 110, LLC. d267ca31-09bd-46d3-be08-a259642f1b7f 2025-10-14 Warnings Exact identifier application number: M001 Magnesium Oxide MAGNESIUM OXIDE A-S Medication Solutions c14d2b4d-d6d8-4293-835e-5d893d5b7e6a 2025-10-10 Warnings Exact identifier application number: M001 Calcium Carbonate Antacid Assorted Berries CALCIUM CARBONATE Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 3f640ccd-4b8d-fc24-e063-6294a90a6e58 2025-09-22 Warnings Exact identifier application number: M001 Stomachin Antacid MAGNESIUM CARBONATE AND SODIUM BICARBONATE Chang Kuo Chou Pharmaceutical Co., Ltd. 60fa0650-8785-4cb3-8f88-1a437296252f 2025-09-19 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