FDA.reportPublic FDA data

Mag-Al Plus XS

Product NDC
55154-9422
11-digit product format
551549422
Labeler code
55154
Product ID
55154-9422_0abd791a-4b77-4f12-9e04-4b8a8a8f8229
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Hydroxide, Aluminum Hydroxide, Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-07
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED
Active strength
2400; 2400; 240 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Skin Barrier Activity [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
Mag-Al Plus XS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE2400 mg/30mL
MAGNESIUM HYDROXIDE2400 mg/30mL
DIMETHICONE, UNSPECIFIED240 mg/30mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-9422-5Mag-Al Plus XS5 in 1 BAGSUSPENSION512
55154-9422-5Mag-Al Plus XS30 mL in 1 CUP, UNIT-DOSESUSPENSION3012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
HYDROXIDE IONACTIVE MOIETY9159UV381PMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
SORBITOLINACTIVE INGREDIENT506T60A25RMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4
WATERINACTIVE INGREDIENT059QF0KO0RMAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9422MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20240123_8ea0287c-2264-4b5d-8f37-2cf3733936c7.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 5 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6701200-eb58-30f1-e053-2a95a90a032e2025-12-10WarningsExact identifier
application number: M002
Motion Sickness ReliefMECLIZINE HCLShield Pharmaceuticals Corp9b5ad2ca-a47b-434a-97b5-8f729740d4ee2025-12-09WarningsExact identifier
application number: M002
CVS Health Maximum StrengthANTACID AND ANTIGASCVS Pharmacy,Inc.0a13ac81-0c63-48c1-bbb0-f6e67f97b8962025-12-04WarningsExact identifier
application number: M002
Quality Choice Infants Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
application number: M002
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
application number: M002
QC Gas Relief Mint FlavorSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)26b83259-744b-4711-a32f-9f8fe5d0555b2025-12-03WarningsExact identifier
application number: M002
Walgreens Infants Dye Free Gas ReliefSIMETHICONEWALGREEN CO.05d2a37f-f47d-40e6-a799-120d846bf5d62025-12-02WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association849802d6-698d-479b-9036-781317a59ade2025-12-02WarningsExact identifier
application number: M002
Walgreens Extra StrengthSIMETHICONEWALGREENS CO.dbd2ed5b-14b1-4bdf-bd0a-84579ca3d8152025-11-25WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASWALGREENS CO.bf6f5463-a88c-4854-be4d-319582e564792025-11-25WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEBJWC (Berkley & Jensen / BJ's)0198f55b-735d-4354-83aa-acdc644af2c92025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEMajor Pharmaceuticals4f445be1-220d-4660-abb2-c24cd33e7ca72025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECardinal Health (Leader) 700004ce6d62c-9321-4b11-94ea-c51a94f351812025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN8ea0287c-2264-4b5d-8f37-2cf3733936c712
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD8ea0287c-2264-4b5d-8f37-2cf3733936c712
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY8ea0287c-2264-4b5d-8f37-2cf3733936c712
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY8ea0287c-2264-4b5d-8f37-2cf3733936c712
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY8ea0287c-2264-4b5d-8f37-2cf3733936c712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9422-5551549422055 CUP, UNIT-DOSE in 1 BAG (55154-9422-5) / 30 mL in 1 CUP, UNIT-DOSE2011-06-070000-00-00NoNoCurrent