MILK OF MAGNESIA

Product NDC
0121-0527
11-digit product format
001210527
Labeler code
0121
Product ID
0121-0527_efa4796f-8973-4fad-e053-2995a90abebf
Type
HUMAN OTC DRUG
Nonproprietary name
MAGNESIUM HYDROXIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1982-04-20
Marketing end
2022-12-30
Substance
MAGNESIUM HYDROXIDE
Active strength
2400 mg/10mL
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0121-0527DDiscontinued by firm2026-08-11
excluded packagepackage0121-05270121-0527-10DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0527-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0527-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-0527-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-0527-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-0527-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-0527-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-0527-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-0527-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-0527-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-0527-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-0527-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-0527-10557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0527-10ML - Milliliter0121-0527a41ec937-7b6f-40dc-8054-c8864451d51612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
PYRROBUTAMINE NAPHTHALENE DISULFONATEINACTIVE INGREDIENT144X0H6HW6MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SORBITOLINACTIVE INGREDIENT506T60A25RMILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]4
SUCROSEINACTIVE INGREDIENTC151H8M554MILK 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
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)INACTIVE INGREDIENT90D834OZUIMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMILK 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
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RMILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0527-100012105271010 TRAY in 1 CASE (0121-0527-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE10 tray1982-04-200000-00-00NoNoCurrent