FDA.reportPublic FDA data

Milk of Magnesia

Product NDC
81033-014
11-digit product format
810330014
Labeler code
81033
Product ID
81033-014_3f7cff50-749c-5275-e063-6394a90af407
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Hydroxide
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1979-09-04
Substance
MAGNESIUM HYDROXIDE
Active strength
400 mg/5mL
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

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE400 mg/5mL

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
3f7cff50-749b-5275-e063-6394a90af407Available 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
81033-014-30Milk of Magnesia30 mL in 1 CUP, UNIT-DOSESUSPENSION301
81033-014-52Milk of Magnesia100 in 1 CASESUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-014-30ML - Milliliter81033-014d8616778-365a-4d08-a850-8d28d62c0ff612025-11-13
81033-014-52ML - Milliliter81033-0143ebe1f74-0115-4a62-9727-4e7b7451429812025-11-13

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 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHILLIPS FRESH MINT MILK OF MAGNESIAPHILLIPS FRESH MINT MILK OF MAGNESIABayer HealthCare LLC.0a59f9c3-c14e-2824-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
application number: M007
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
application number: M007
PHILLIPS ORIGINAL MILK OF MAGNESIAPHILLIPS ORIGINAL MILK OF MAGNESIABayer HealthCare LLC.0a57bb45-d4f7-443b-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
application number: M007
Gentle Laxative Stimulant LaxativeBISACODYLQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)bcd3c07d-bd83-4452-9736-35c85db30c152025-12-03WarningsExact identifier
application number: M007
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
application number: M007
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
application number: M007
CDMA Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION62bbcaf2-1d0c-485f-9159-685700aa34182025-12-03WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
application number: M007
Magnesium CitrateEPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON4 Visions LLC44fe65d0-ee46-1d95-e063-6294a90abb712025-12-02WarningsExact identifier
application number: M007
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
application number: M007
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
application number: M007
Walgreens Fiber TherapyMETHYLCELLULOSEWALGREENS CO.6401a2c3-5869-4898-81db-3cd7151ca69a2025-11-25WarningsExact identifier
application number: M007
Walgreens Senna LaxativeSENNOSIDESWALGREENS CO.a95bd796-d85e-4599-bbb1-2170088fa9372025-11-25WarningsExact identifier
application number: M007
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN3f7cff50-749b-5275-e063-6394a90af4071
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD3f7cff50-749b-5275-e063-6394a90af4071
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY3f7cff50-749b-5275-e063-6394a90af4071
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY3f7cff50-749b-5275-e063-6394a90af4071
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY3f7cff50-749b-5275-e063-6394a90af4071
253017milk of magnesia 8 % Oral SuspensionSY3f7cff50-749b-5275-e063-6394a90af4071
253017milk of magnesia 80 MG/ML Oral SuspensionSY3f7cff50-749b-5275-e063-6394a90af4071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-014-308103300143030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
81033-014-5281033001452100 CUP, UNIT-DOSE in 1 CASE (81033-014-52) / 30 mL in 1 CUP, UNIT-DOSE (81033-014-30) 2025-09-23NoNoCurrent