FDA.reportPublic FDA data

GAVISCON

Product NDC
0135-0095
11-digit product format
001350095
Labeler code
0135
Product ID
0135-0095_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
2011-01-14
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
5QB0T2IUN0Internal UNII lookup
0E53J927NAInternal 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
0135-0095-41GAVISCON355 mL in 1 BOTTLELIQUID35523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0095-41ML - Milliliter0135-00958a89799b-6ea4-41da-b54a-56f8d61cdd0812012-07-24

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
0135-0095GAVISCON (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 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 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
0135-0095-4100135009541355 mL in 1 BOTTLE (0135-0095-41) 355 ml2011-01-140000-00-00NoNoCurrent