FDA.reportPublic FDA data

EXTRA STRENGTH HEARTBURN RELIEF

Product NDC
69842-628
11-digit product format
698420628
Labeler code
69842
Product ID
69842-628_09079688-4a35-fb60-e063-6394a90ae488
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS PHARMACY,INC.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-01
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
EXTRA STRENGTH 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
53fc327e-e345-26f2-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-628-12EXTRA STRENGTH HEARTBURN RELIEF355 mL in 1 BOTTLESUSPENSION3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-628EXTRA STRENGTH HEARTBURN RELIEF (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) SUSPENSION [CVS PHARMACY,INC.]2Current NDC, Legacy NDC, 1 package rows20231101_53fc327e-e345-26f2-e054-00144ff8d46c.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 30 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodsense Extra Strength AntacidCALCIUM CARBONATEGoodSense193a1805-9f57-29cd-e063-6394a90ab99f2024-09-13WarningsExact identifier
application number: M001
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
application number: M001
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
application number: M001
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
application number: M001
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC72ac000c-90f7-42e2-88a6-740de114a9542024-08-21WarningsExact identifier
application number: M001
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
application number: M001
Wonderbelly Maximum Strength Antacid - Sweet MintCALCIUM CARBONATEGinger Health Company17ddf76b-237a-eeee-e063-6294a90ac2052024-07-29WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Regular StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation2847e82e-203e-4976-8c4f-4a5caa75ce002024-07-09WarningsExact identifier
application number: M001
Kirkland Ultra Stregth Antacid 171ABCALCIUM CARBONATECOSTCO WHOLESALE COMPANY1bea92e8-1b94-77b0-e063-6394a90a82122024-07-08WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa951fa64-7775-470e-e053-2995a90aefc42024-06-10WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals,Inc.5b1f4c78-d42e-32c7-e053-2991aa0a19852024-06-04WarningsExact identifier
application number: M001
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
application number: M001
Stomach Circle KBISMUTH SUBSALICYLATELil' Drug Store Products, Inc05e14009-b35d-4711-b6f0-89b6d060b3872024-05-06WarningsExact identifier
application number: M001
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
application number: M001
MINT ANTACID 100CALCIUM CARBONATEJHK Inc dba American Safety & First Aid2496aed6-68ec-44c4-afc9-f7fa41b2147b2024-04-24WarningsExact identifier
application number: M001
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
application number: M001
Gas-X Maximum Strength SoftgelsSIMETHICONEHaleon US Holdings LLC45d1e373-0717-47df-9160-619c451666f42024-04-05WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact 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 SuspensionPSN53fc327e-e345-26f2-e054-00144ff8d46c2
245001aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral SuspensionSCD53fc327e-e345-26f2-e054-00144ff8d46c2
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG per 5 ML Oral SuspensionSY53fc327e-e345-26f2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-628-1269842062812355 mL in 1 BOTTLE (69842-628-12) 355 ml2017-02-010000-00-00NoNoCurrent