FDA.reportPublic FDA data

Milk of Magnesia

Product NDC
0121-0431
11-digit product format
001210431
Labeler code
0121
Product ID
0121-0431_57f5d77e-6712-4cd8-8299-3fe42ff67aef
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Hydroxide
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1979-09-04
Substance
MAGNESIUM HYDROXIDE
Active strength
2400 mg/30mL
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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE2400 mg/30mL

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
2de868a0-c652-473c-8b61-636083b7f757Available 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0431-30Milk of Magnesia10 in 1 TRAYSUSPENSION106
0121-0431-30Milk of Magnesia10 in 1 CASESUSPENSION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0431-30ML - Milliliter0121-04318f8054f2-185a-40d8-992f-43c890584ab412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
HYDROXIDE IONACTIVE MOIETY9159UV381PMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SORBITOLINACTIVE INGREDIENT506T60A25RMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
WATERINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
Magnesium HydroxideACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
HYDROXIDE IONACTIVE MOIETY9159UV381PMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
CYCLOMETHICONE 4INACTIVE INGREDIENTCZ227117JEMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0431MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PAI HOLDINGS, LLC]6Current NDC, Legacy NDC, 2 package rows20241121_2de868a0-c652-473c-8b61-636083b7f757.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 32 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017milk of magnesia 8 % Oral SuspensionSY144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017milk of magnesia 80 MG/ML Oral SuspensionSY144c7242-4ff9-404a-86bf-48e2871eb0cd13
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN2de868a0-c652-473c-8b61-636083b7f7576
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD2de868a0-c652-473c-8b61-636083b7f7576
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY2de868a0-c652-473c-8b61-636083b7f7576
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY2de868a0-c652-473c-8b61-636083b7f7576
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY2de868a0-c652-473c-8b61-636083b7f7576
253017milk of magnesia 8 % Oral SuspensionSY2de868a0-c652-473c-8b61-636083b7f7576
253017milk of magnesia 80 MG/ML Oral SuspensionSY2de868a0-c652-473c-8b61-636083b7f7576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0431-300012104313010 TRAY in 1 CASE (0121-0431-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE10 tray1979-09-040000-00-00NoNoCurrent