FDA.reportPublic FDA data

Mag-Al Plus

Product NDC
55154-9429
11-digit product format
551549429
Labeler code
55154
Product ID
55154-9429_4bd8e724-0d46-4734-9b75-62acc758ff10
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, and simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-07
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED
Active strength
200; 200; 20 mg/5mL; mg/5mL; 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], Skin Barrier Activity [PE], 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
Mag-Al Plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE200 mg/5mL
MAGNESIUM HYDROXIDE200 mg/5mL
DIMETHICONE, UNSPECIFIED20 mg/5mL

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
307746Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08df7403-9ee3-4a43-a151-c1a6ef7a7549Available 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
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
55154-9429-5Mag-Al Plus30 mL in 1 CUP, UNIT-DOSESUSPENSION3015
55154-9429-5Mag-Al Plus5 in 1 BAGSUSPENSION515

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9429MAG-AL PLUS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE) SUSPENSION [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 2 package rows20250514_08df7403-9ee3-4a43-a151-c1a6ef7a7549.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 18 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Smooth AntacidANTACID TABLETSWal-Mart Stores,Inc.,92372491-000d-4273-a668-b87722c1d3812025-10-27WarningsExact identifier
application number: M001
equate Extra Strength Smooth Antacid Assorted BerriesANTACID TABLETSWal-Mart Stores,Inc.,cc93e3b4-adbc-4a2c-b6fc-bf7456ef16562025-10-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEKesin Pharma31f417f0-1637-eefa-e063-6294a90a121b2025-10-27WarningsExact identifier
application number: M001
Rugby Extra Strength Assorted BerriesANTACID TABLETSRugby Laboratoriesb0fcfd66-276e-4741-9aee-915b6364f25c2025-10-25WarningsExact identifier
application number: M001
RugbyANTACID TABLETSRugby Laboratories9cb56bc3-7075-4f81-bd10-7e602034b7d82025-10-25WarningsExact identifier
application number: M001
Rugby Cal-Gest Antacid Assorted FlavorsANTACID TABLETSRugby Laboratories, Inc.a43184c4-d225-4539-b651-4d96535f208f2025-10-25WarningsExact identifier
application number: M001
Super vitamin C serumSUPER VITAMIN CFlexiGo Inc41cbe84e-3ddf-b806-e063-6294a90a55a42025-10-22WarningsExact identifier
application number: M001
Exchange Select Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEArmy & Air Force Exchange Service41ad5581-5b8a-1c8b-e063-6294a90a2ba62025-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEMethod Pharmaceuticals, LLC0af63651-f9d9-43b9-b6f0-4878466a82e62025-10-21WarningsExact identifier
application number: M001
CardinalExtra Strength Antacid Wintergreen flavorCALCIUM CARBONATECARDINAL HEALTH4e40989f-c710-442a-bb8d-02e813ddf04d2025-10-14WarningsExact identifier
application number: M001
Regular Strength Antacid Assorted FruitCALCIUM CARBONATECARDINAL HEALTHdef9eaef-308f-49f2-898b-469c2c395d272025-10-14WarningsExact identifier
application number: M001
Leader Extra Strength Sugar Free AntacidANTACIDCardinal Healthd7a6f1b8-bdf7-45bb-bab0-b22f45e784402025-10-14WarningsExact identifier
application number: M001
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECardinal Health1fe459f6-be7f-4c59-b33b-f13ec17071f22025-10-14WarningsExact identifier
application number: M001
Cardinal Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATECARDINAL HEALTH84bf7fea-a071-4583-9453-1aea4d198ca62025-10-14WarningsExact identifier
application number: M001
ANTACID Extra StrengthCALCIUM CARBONATECardinal Health 110, LLC.3ce9b97b-1680-4299-9a2c-132318adbc0c2025-10-14WarningsExact identifier
application number: M001
ANTACID Extra StrengthCALCIUM CARBONATECARDINAL HEALTH 110, LLC.7c1b2ee6-b691-4c12-bed5-f0a360ad46bb2025-10-14WarningsExact identifier
application number: M001
ANTACID Ultra StrengthCALCIUM CARBONATECARDINAL HEALTH 110, LLC.d267ca31-09bd-46d3-be08-a259642f1b7f2025-10-14WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEA-S Medication Solutionsc14d2b4d-d6d8-4293-835e-5d893d5b7e6a2025-10-10WarningsExact identifier
application number: M001
Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3f640ccd-4b8d-fc24-e063-6294a90a6e582025-09-22WarningsExact identifier
application number: M001
Stomachin AntacidMAGNESIUM CARBONATE AND SODIUM BICARBONATEChang Kuo Chou Pharmaceutical Co., Ltd.60fa0650-8785-4cb3-8f88-1a437296252f2025-09-19WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN08df7403-9ee3-4a43-a151-c1a6ef7a754915
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD08df7403-9ee3-4a43-a151-c1a6ef7a754915
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY08df7403-9ee3-4a43-a151-c1a6ef7a754915
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY08df7403-9ee3-4a43-a151-c1a6ef7a754915
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY08df7403-9ee3-4a43-a151-c1a6ef7a754915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9429-5551549429055 CUP, UNIT-DOSE in 1 BAG (55154-9429-5) / 30 mL in 1 CUP, UNIT-DOSE2011-06-070000-00-00NoNoCurrent