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 13 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.84771ac5-ad0b-e0ec-e053-2a91aa0a1b362025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.bdb43d3b-ddcd-4359-a174-a5556e7c5f572025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.7857c357-38cb-2f61-e053-2991aa0a66022025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
application number: M001
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
application number: M001
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
application number: M001
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
application number: M001
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
application number: M001
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
application number: M001
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
application number: M001
Quality Choice Ultra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION63318b46-d47d-474c-8fb5-5e0d53b7adb42025-12-03WarningsExact identifier
application number: M001
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.8064b01a-e049-4d49-a5b6-e72dbeb5daac2025-12-03WarningsExact identifier
application number: M001
calcium antacidextra strength extra strengthCALCIUM CARBONATERugby Laboratoriesd761954f-940e-4833-87b7-173a921aade12025-12-03WarningsExact 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