FDA.reportPublic FDA data

GAVISCON

Product NDC
0135-0574
11-digit product format
001350574
Labeler code
0135
Product ID
0135-0574_4aba2043-4dde-0c18-e063-6294a90a5fcf
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-01
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
254; 237.5 mg/5mL; mg/5mL
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
GAVISCON
Listing expiration
2027-12-31

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
0E53J927NAInternal UNII lookup
5QB0T2IUN0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245001Internal RxNorm lookup
252203Internal RxNorm lookup
404472Internal RxNorm lookup
1251365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d74e5bc-1f10-4fb6-9258-cd906e360013Available 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
0135-0574-01GAVISCON355 mL in 1 BOTTLELIQUID35523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0574-01ML - Milliliter0135-0574acc128fb-e721-46a0-a8c7-3a2e2348920512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
SORBITOLINACTIVE INGREDIENT506T60A25RGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
WATERINACTIVE INGREDIENT059QF0KO0RGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0574GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) LIQUID [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 1 package rows20250529_2d74e5bc-1f10-4fb6-9258-cd906e360013.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 SuspensionPSN2d74e5bc-1f10-4fb6-9258-cd906e36001323
252203aluminum hydroxide 95 MG / magnesium carbonate 358 MG in 15 mL Oral SuspensionPSN2d74e5bc-1f10-4fb6-9258-cd906e36001323
404472Gaviscon Extra Strength 254 MG / 237.5 MG in 5 mL Oral SuspensionPSN2d74e5bc-1f10-4fb6-9258-cd906e36001323
1251365Gaviscon Regular Strength 95 MG / 358 MG in 15 mL Oral SuspensionPSN2d74e5bc-1f10-4fb6-9258-cd906e36001323
404472aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral Suspension [Gaviscon]SBD2d74e5bc-1f10-4fb6-9258-cd906e36001323
1251365aluminum hydroxide 6.33 MG/ML / magnesium carbonate 23.9 MG/ML Oral Suspension [Gaviscon]SBD2d74e5bc-1f10-4fb6-9258-cd906e36001323
245001aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral SuspensionSCD2d74e5bc-1f10-4fb6-9258-cd906e36001323
252203aluminum hydroxide 6.33 MG/ML / magnesium carbonate 23.9 MG/ML Oral SuspensionSCD2d74e5bc-1f10-4fb6-9258-cd906e36001323
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG per 5 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
252203aluminum hydroxide 31.7 MG / magnesium carbonate 119.3 MG per 5 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
252203aluminum hydroxide 32 MG / magnesium carbonate 119 MG per 5 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
252203aluminum hydroxide 95 MG / magnesium carbonate 358 MG per 15 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
1251365Gaviscon (aluminum hydroxide 31.7 MG / magnesium carbonate 119.3 MG) per 5 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
1251365Gaviscon (aluminum hydroxide 95 MG / magnesium carbonate 358 MG) per 15 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323
404472Gaviscon Extra Strength Liquid (aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG) per 5 ML Oral SuspensionSY2d74e5bc-1f10-4fb6-9258-cd906e36001323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0574-0100135057401355 mL in 1 BOTTLE (0135-0574-01) 355 ml2014-08-010000-00-00NoNoCurrent