FDA.reportPublic FDA data

Aluminum hydroxide and Magnesium carbonate

Product NDC
76457-001
11-digit product format
764570001
Labeler code
76457
Product ID
76457-001_0b5850de-34f4-b95e-e063-6294a90affe1
Type
HUMAN OTC DRUG
Nonproprietary name
ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Simpex Pharma Pvt. Ltd
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-09
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
160; 105 mg/1; mg/1
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 and Magnesium carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE160 mg/1
MAGNESIUM CARBONATE105 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
0E53J927NAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e799a555-bfd0-4298-a5dc-aeb671815d40Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76457-001-00Aluminum hydroxide and Magnesium carbonate1 in 1 CARTONTABLET, CHEWABLE17
76457-001-00Aluminum hydroxide and Magnesium carbonate100 in 1 BOTTLETABLET, CHEWABLE1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
SUCROSEINACTIVE INGREDIENTC151H8M554ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3
WATERINACTIVE INGREDIENT059QF0KO0RALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76457-001ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]7Current NDC, Legacy NDC, 2 package rows20231201_e799a555-bfd0-4298-a5dc-aeb671815d40.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 34 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY,INC.53fc327e-e345-26f2-e054-00144ff8d46c2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
application number: M001
CALCIUM CARBONATE CHEWABLE ANTACIDCALCIUM CARBONATEGeri-Care Pharmaceutical Corp27d9b505-08bd-4261-a59d-6ddc4031be322023-10-25WarningsExact identifier
application number: M001
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd5c123f8-1396-4d8c-96d3-e5ade96a6ef82020-11-10WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
application number: M001
Magnesium Oxide 400mgMAGNESIUM OXIDE 400MGAllegiant Health2ea68874-8c20-4284-bd0a-f07768057b832019-01-28WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health51dd53e8-22ff-4967-9124-f15c3986e4dd2017-11-17WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health551d6135-2650-4c27-a20d-d56a9aba7b712017-11-08WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSNe799a555-bfd0-4298-a5dc-aeb671815d407
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCDe799a555-bfd0-4298-a5dc-aeb671815d407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76457-001-00764570001001 BOTTLE in 1 CARTON (76457-001-00) / 100 TABLET, CHEWABLE in 1 BOTTLE1 bottle2018-02-090000-00-00NoNoCurrent