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

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 Identifiers#

Field, Values table
FieldValues
UniiNBZ3QY004S
Rxcui253017

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

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