FDA.reportPublic FDA data

HEARTBURN RELIEF

Product NDC
57896-565
11-digit product format
578960565
Labeler code
57896
Product ID
57896-565_28d955ae-eec6-64fc-e063-6294a90a154d
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
SUSPENSION
Route
ORAL
Labeler
GERI-CARE PHARMACEUTICALS, CORP
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
254; 237.5 mg/5mL; mg/5mL
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
HEARTBURN RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE254 mg/5mL
MAGNESIUM CARBONATE237.5 mg/5mL

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
245001Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f1dbf41-cb87-37d4-e063-6394a90ae294Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-565-12HEARTBURN RELIEF355 mL in 1 BOTTLESUSPENSION3552

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-565-12ML - Milliliter57896-565f399eaca-369d-4059-b040-e51e6a15fef712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-565HEARTBURN RELIEF (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) SUSPENSION [GERI-CARE PHARMACEUTICALS, CORP]2Current NDC, 1 package rows20241210_1f1dbf41-cb87-37d4-e063-6394a90ae294.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 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
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG in 5 mL Oral SuspensionPSN1f1dbf41-cb87-37d4-e063-6394a90ae2942
245001aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral SuspensionSCD1f1dbf41-cb87-37d4-e063-6394a90ae2942
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG per 5 ML Oral SuspensionSY1f1dbf41-cb87-37d4-e063-6394a90ae2942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57896-565-1257896056512355 mL in 1 BOTTLE (57896-565-12) 355 ml2024-07-01NoNoCurrent