FDA.reportPublic FDA data

Antacid

Product NDC
53041-509
11-digit product format
530410509
Labeler code
53041
Product ID
53041-509_d577828d-8a47-4a16-b1a5-3628679b3fe5
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-26
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
400; 400; 40 mg/10mL; mg/10mL; mg/10mL
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
Antacid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/10mL
MAGNESIUM HYDROXIDE400 mg/10mL
DIMETHICONE40 mg/10mL

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
48ec50ab-f24b-367b-e063-6294a90ad736Available on FDA.report

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 1 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
application number: M001
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
application number: M001
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
application number: M001
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
application number: M001
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEDOLGENCORP, LLC98a0503c-add5-4453-9d9d-6f813866f4b32026-09-03WarningsExact identifier
application number: M001
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
application number: M001
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC4942747a-8b6c-422a-8150-9bd91c0a37782026-09-03WarningsExact identifier
application number: M001
DG HEALTH Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLC13dd2758-a372-4b0e-bc99-56a2dacbf95f2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Antacid Wintergreen flavorCALCIUM CARBONATEDOLGENCORP, LLCb84b3509-3178-4616-9bec-dad85a4f9d2a2026-09-03WarningsExact identifier
application number: M001
DG Health Regular Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC59ad3cc7-4144-442f-a37d-75c5fe23e1ae2026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength Assorted Fruits AntacidCALCIUM CARBONATEDOLGENCORP, LLC112f1002-c007-4363-ade6-8dfbc61f4b642026-09-03WarningsExact identifier
application number: M001
DG health Extra Strength AntacidSMOOTH DISSOLVE CALCIUM CARBONATEDOLGENCORP, LLCcabaa8f7-9c93-439d-905a-5ef643a08ea82026-09-03WarningsExact identifier
application number: M001
Kroger Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETHE KROGER CO.,175d9f0f-266a-4dc2-865f-d1ebd4ddac512026-09-01WarningsExact identifier
application number: M001
Kids AntacidCALCIUM CARBONATETHE KROGER CO.d77c629b-5308-4b71-9024-9899cf88dbae2026-09-01WarningsExact identifier
application number: M001
Kroger Extra Strength Smooth Antacid Assorted BerryCALCIUM CARBONATEKROGER COMPANY4c8d39d9-9d58-45df-9ffd-2cdc41539c032026-09-01WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-509-0553041050905355 mL in 1 BOTTLE (53041-509-05) 355 ml2026-08-26NoNoCurrent