FDA.reportPublic FDA data

Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone

Product NDC
0904-7557
11-digit product format
009047557
Labeler code
0904
Product ID
0904-7557_a1959779-7777-44f0-b9bc-2dcab570365e
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-07
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
1200; 1200; 120 mg/30mL; mg/30mL; mg/30mL
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
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
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE1200 mg/30mL
MAGNESIUM HYDROXIDE1200 mg/30mL
DIMETHICONE120 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
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
1bc90fa7-fcce-4a9b-862f-f30ab602ecabAvailable 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
0904-7557-62Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION3010
0904-7557-73Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone10 in 1 TRAYSUSPENSION1010
0904-7557-73Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone10 in 1 CASESUSPENSION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7557-62ML - Milliliter0904-755798b9340d-d731-4f8b-9d98-0250ee044f9f12025-08-11
0904-7557-73ML - Milliliter0904-755710486a14-a84a-45e8-b285-ed750e0258bf12025-08-11

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 15 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5e996df3-25a4-b259-e053-2a91aa0a43112025-11-19WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpa7d7298f-44d6-4e09-8578-7fe3112430022025-11-19WarningsExact identifier
application number: M001
GERI-MOX MAX CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp8e57bcf5-2960-4c41-8bf2-83cb1ee501682025-11-19WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGR J General Corporation6208d11d-0670-4a20-a3fc-ebc764a8e6cd2025-11-17WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
application number: M001
Antacid ChildrensCALCIUM CARBONATECVS Pharmacy08953df1-cc29-452f-bc69-b19970a1fd2e2025-11-15WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc0bb322a5-fb92-14de-e063-6294a90a4c1b2025-11-14WarningsExact identifier
application number: M001
magnesium oxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc.dc57893c-068a-37d8-e053-2a95a90aa0542025-11-14WarningsExact identifier
application number: M001
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
application number: M001
Topcare Antacid Extra Strength Assorted BerryCALCIUM CARBONATETopco Associates LLC14f6f475-32d6-4783-8dcc-1fe265902d552025-11-10WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC38c26f49-fb5e-480c-9164-bf5edcf0726b2025-11-10WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC.bb99b942-1f84-43e1-a18d-3a975cddc59e2025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Regular StrengthCALCIUM CARBONATETopco Associates LLC2606ac08-9760-4ff6-8d90-51fbb04e6ac82025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC495d97b0-d95c-46d1-a76a-56ac7f8235382025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC.73b4cda2-900a-4380-a0ae-0abfecdb72632025-11-08WarningsExact identifier
application number: M001
Topcare Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates LLC2677ca2b-b211-475e-a9c4-643fd54a744f2025-11-08WarningsExact identifier
application number: M001
TopCare Antacid CalciumCALCIUM CARBONATETopco Associates LLCb94eac38-62d0-49a2-bb49-053fda8129e22025-11-08WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC04b3d397-df99-44e2-a191-6e9199b083982025-11-08WarningsExact identifier
application number: M001
topcare Antacid Calcium Ultra StrengthCALCIUM CARBONATETopco Associates LLC6e2788b3-1e33-4908-aa2c-475d69b94ee62025-11-08WarningsExact 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 SuspensionPSN1bc90fa7-fcce-4a9b-862f-f30ab602ecab10
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD1bc90fa7-fcce-4a9b-862f-f30ab602ecab10
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY1bc90fa7-fcce-4a9b-862f-f30ab602ecab10
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY1bc90fa7-fcce-4a9b-862f-f30ab602ecab10
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY1bc90fa7-fcce-4a9b-862f-f30ab602ecab10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7557-620090475576230 mL in 1 CUP, UNIT-DOSE30 mlHistorical
0904-7557-730090475577310 TRAY in 1 CASE (0904-7557-73) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0904-7557-62) 10 tray2025-07-07NoNoCurrent