Home NDC 0603-0209 Magnesium Oxide
Product NDC 0603-0209
11-digit product format 006030209
Labeler code 0603
Product ID 0603-0209_13cbf8b0-0af9-4cea-b217-e88ab22d1b16
Type HUMAN OTC DRUG
Nonproprietary name Magnesium Oxide
Dosage form TABLET
Route ORAL
Labeler Par Health
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 2027-12-31
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 25 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcium Carbonate 1250 mg CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 766b3f3f-8bd1-281c-e053-2991aa0af54b 2025-01-30 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 723b940d-4f4b-f2e6-e053-2991aa0a8bcc 2025-01-30 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE CVS 2bc4c71c-a9c5-17df-e063-6294a90ac88c 2025-01-27 Warnings Exact identifier application number: M001 Goodsense Ultra Strength Antacid CALCIUM CARBONATE Good Sense (Geiss, Destin & Dunn, Inc.) 492deace-7ea1-4fe3-a4c7-b2c6f195d68c 2025-01-20 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Ulai Health LLC 641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a 2025-01-20 Warnings Exact identifier application number: M001 GoodSense Extra Strength Antacid CALCIUM CARBONATE GoodSense 2fcdeb06-17de-49d8-97bb-8d31e1c0c61f 2025-01-20 Warnings Exact identifier application number: M001 HEB Extra Stregth Antacid CALCIUM CARBONATE H E B dcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e48 2025-01-20 Warnings Exact identifier application number: M001 Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE Everpharm LLC 2bda74cb-e77d-46bb-e063-6394a90af580 2025-01-16 Warnings Exact identifier application number: M001 Childrens Antacid CALCIUM CARBONATE CVS 1bf90c0c-b639-1c06-e063-6394a90ab85b 2025-01-16 Warnings Exact identifier application number: M001 Sodium Bicarbonate SODIUM BICARBONATE World Perfumes Inc a83544e4-ec09-1e95-e053-2995a90ab7b9 2025-01-15 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr SODIUM BICARBONATE Reliable 1 Laboratories LLC 321a772c-c44c-3d4e-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Calcium Carbonate 500 mg CALCIUM CARBONATE Reliable 1 Laboratories LLC 322f1b54-abe9-11a7-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a27a71-b7b2-12aa-e063-6294a90a312f 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a7720f-1e74-7578-e063-6394a90a5eae 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78060-7f0d-c4bd-e063-6294a90ae152 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78a5c-e3b5-f362-e063-6394a90a0807 2025-01-15 Warnings Exact identifier application number: M001 Rolaids Extra Strength Mint CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. 604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e 2025-01-15 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE H E B 19a3221f-e0c1-c47a-e063-6394a90a1f01 2025-01-14 Warnings Exact identifier application number: M001 Childrens Stomach Relief Antacid CALCIUM CARBONATE H E B 18fae1aa-1001-8035-e063-6394a90adc66 2025-01-14 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Aphena Pharma Solutions - Tennessee, LLC ac839363-94fd-4c60-b5b6-70e4488ce1dd 2025-01-09 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