FDA.reportPublic FDA data

MILK OF MAGNESIA ORIGINAL

Product NDC
0904-0788
11-digit product format
009040788
Labeler code
0904
Product ID
0904-0788_45afc92c-55cc-0488-e063-6394a90a7b0d
Type
HUMAN OTC DRUG
Nonproprietary name
magnesium hydroxide
Dosage form
LIQUID
Route
ORAL
Labeler
MAJOR Pharmaceuticals Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-08
Substance
MAGNESIUM HYDROXIDE
Active strength
1200 mg/15mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-07880904-0788-14DDiscontinued by firm2026-10-16

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
MILK OF MAGNESIA ORIGINAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE1200 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
253017Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
673311f7-0b83-410c-a480-8e57d0190296Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-0788-14MILK OF MAGNESIA ORIGINAL355 mL in 1 BOTTLELIQUID3555
0904-0788-16MILK OF MAGNESIA ORIGINAL473 mL in 1 BOTTLELIQUID4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0788-14ML - Milliliter0904-07882ec21e5a-76da-4529-bf16-65931e967b2912012-07-24
0904-0788-16ML - Milliliter0904-0788ffb3204a-7af4-4e4d-a6c6-2776e1356ce912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [ATLANTIC BIOLOGICALS CORPS]7
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [ATLANTIC BIOLOGICALS CORPS]7
SODIUM HYPOCHLORITEINACTIVE INGREDIENTDY38VHM5ODMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [ATLANTIC BIOLOGICALS CORPS]7
WATERINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [ATLANTIC BIOLOGICALS CORPS]7
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
MAGNESIUM HYDROXIDEACTIVE MOIETYNBZ3QY004SMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
SODIUM HYPOCHLORITEINACTIVE INGREDIENTDY38VHM5ODMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
SODIUM HYPOCHLORITEINACTIVE INGREDIENTDY38VHM5ODMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [LLC FEDERAL SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [LLC FEDERAL SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-0788MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID [MAJOR PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20231103_673311f7-0b83-410c-a480-8e57d0190296.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 14 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENTLE LAXATIVEBISACODYLWal-Mart Stores Inc9b466e37-4c7d-4237-8a9d-2994113707f42026-01-26WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Laboratories Limited3cf42333-7479-940a-e063-6394a90aedee2026-01-23WarningsExact identifier
application number: M007
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2de868a0-c652-473c-8b61-636083b7f7572026-01-22WarningsExact identifier
application number: M007
Dr Simi Regular Strength Sennosides 8.6mgSENNOSIDES 8.6MGFarmacias De Similares TX LLC48ed4c5a-136a-90ba-e063-6294a90affed2026-01-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC1f6c3b64-0fcd-4cd3-9947-453d794682922026-01-19WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreensd094ba43-7404-43c4-b907-41ab6d02a3c32026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens015e41d2-7543-4210-8345-626f5ae5f81d2026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens2c30de62-b5d2-4905-90a1-a2f9a339fb272026-01-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)0ce164a5-6b2f-4a21-9dca-10301a1f812a2026-01-15WarningsExact identifier
application number: M007
Dulcolax Pink Stool SoftenerDOCUSATE SODIUMChattem, Inc.33fefcf1-9985-4797-9a38-8acaf3979fce2026-01-14WarningsExact identifier
application number: M007
SennaSENNOSIDESAmerican Health Packaginge3cbb71b-b45c-4ce1-820b-959dde04360d2026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy9c6a651a-f062-4784-9d82-156f9f7452232026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy10a9bd9a-181b-69ba-e063-6294a90ac4582026-01-14WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN30fb7b5e-56a3-423e-ae57-432006b54fff11
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD30fb7b5e-56a3-423e-ae57-432006b54fff11
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY30fb7b5e-56a3-423e-ae57-432006b54fff11
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY30fb7b5e-56a3-423e-ae57-432006b54fff11
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY30fb7b5e-56a3-423e-ae57-432006b54fff11
253017milk of magnesia 8 % Oral SuspensionSY30fb7b5e-56a3-423e-ae57-432006b54fff11
253017milk of magnesia 80 MG/ML Oral SuspensionSY30fb7b5e-56a3-423e-ae57-432006b54fff11
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN673311f7-0b83-410c-a480-8e57d01902965
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD673311f7-0b83-410c-a480-8e57d01902965
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY673311f7-0b83-410c-a480-8e57d01902965
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY673311f7-0b83-410c-a480-8e57d01902965
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY673311f7-0b83-410c-a480-8e57d01902965
253017milk of magnesia 8 % Oral SuspensionSY673311f7-0b83-410c-a480-8e57d01902965
253017milk of magnesia 80 MG/ML Oral SuspensionSY673311f7-0b83-410c-a480-8e57d01902965
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSNca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSNe10f3ee8-c526-40bc-b81f-46696ee310f11
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCDe10f3ee8-c526-40bc-b81f-46696ee310f11
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCDca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSYca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSYe10f3ee8-c526-40bc-b81f-46696ee310f11
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSYca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSYe10f3ee8-c526-40bc-b81f-46696ee310f11
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSYca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSYe10f3ee8-c526-40bc-b81f-46696ee310f11
253017milk of magnesia 8 % Oral SuspensionSYca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017milk of magnesia 8 % Oral SuspensionSYe10f3ee8-c526-40bc-b81f-46696ee310f11
253017milk of magnesia 80 MG/ML Oral SuspensionSYca79f80f-49f2-40f5-a2cb-c9d3de7b9b9e1
253017milk of magnesia 80 MG/ML Oral SuspensionSYe10f3ee8-c526-40bc-b81f-46696ee310f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0788-1400904078814355 mL in 1 BOTTLE (0904-0788-14) 355 ml2017-02-010000-00-00NoNoCurrent
0904-0788-1600904078816473 mL in 1 BOTTLE (0904-0788-16) 473 ml2017-02-010000-00-00NoNoCurrent