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 4 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLCef9ecb48-b394-4a85-8ba8-aa397d20cd842026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLC49bd9752-ddfd-4cb1-bef6-22b4e5b95a372026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC1858cf76-cf36-4c56-9e15-14db609aa10f2026-08-07WarningsExact identifier
application number: M001
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
application number: M001
LYOPHILIZED AMNION WITH ALBUMINHUMAN AMNIOTIC MEMBRANEGuangzhou Yilong Cosmetics.,Ltd57c5a5a5-bbd1-27c3-e063-6294a90a74532026-08-02WarningsExact identifier
application number: M001
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
application number: M001
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
application number: M001
Best Choice Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)BEST CHOICE (VALU MERCHANDISERS COMPANY)1547b549-efd0-46da-8f91-3d7e4d4a2f3a2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Tropical FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)09e25e8e-a861-45cb-a919-36c30d3b7f7b2026-07-17WarningsExact identifier
application number: M001
LEADER ULTRA STRENGTHANTACID CALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER713c74bf-f586-4c63-82aa-5ed3a611d7a02026-07-17WarningsExact identifier
application number: M001
Best Choice Regular StrengthCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd2026-07-17WarningsExact identifier
application number: M001
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthCALCIUM CARBONATE ,MAGNESIUM HYDROXIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)1989551d-b977-4d5e-8b01-153cd9d638fc2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Assorted BerryCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)412a5be3-2f90-483c-8169-b733861f3aa12026-07-17WarningsExact identifier
application number: M001
Best Choice Assorted FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)cd9e2e11-25a8-4096-870a-9d0269e6c7a92026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthSMOOTH ANTACID TABLETSBEST CHOICE (VALU MERCHANDISERS COMPANY)c5141eb9-d851-453e-b51c-f436a647495a2026-07-17WarningsExact identifier
application number: M001
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
application number: M001
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
application number: M001
Amazon Basics Cherry Antacid SCCALCIUM CARBONATEAmazon4b1d6e4e-8b59-ec06-e063-6394a90aa60d2026-07-15WarningsExact 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