FDA.reportPublic FDA data

Mag-Al Plus XS

Product NDC
55154-9422
11-digit product format
551549422
Labeler code
55154
Product ID
55154-9422_0e5449db-1064-409f-a417-98dada2638b7
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; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE
Active strength
2400; 240; 2400 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED322e6cb3-0ddc-9300-e063-6294a90a972a2026-07-18WarningsExact identifier
application number: M002
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
application number: M002
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
application number: M002
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
application number: M002
Tea Tree Oil AntifungalTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.55a48fc6-1963-66ea-e063-6294a90a35012026-07-02WarningsExact identifier
application number: M002
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
application number: M002
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
application number: M002
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
application number: M002
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact identifier
application number: M002

Additional Listing Data#

Finished product
Yes
Brand name base
Mag-Al Plus XS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE2400 mg/30mL
MAGNESIUM HYDROXIDE240 mg/30mL
DIMETHICONE, UNSPECIFIED2400 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
NBZ3QY004SInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237870Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ea0287c-2264-4b5d-8f37-2cf3733936c7Available on FDA.report

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

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