Gaviscon

Product NDC
0135-0098
11-digit product format
001350098
Labeler code
0135
Product ID
0135-0098_02f611d3-df31-4514-86ae-9e81004acdbf
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-13
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
160; 105 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0098-26UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0098-26UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0135-0098-26UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0135-0098-26IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-0098-26IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE160 mg/1
MAGNESIUM CARBONATE105 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
212978Internal RxNorm lookup
308072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f367927-c366-465c-a059-e2cfb337d562Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-02-01Drug Facts
2023-04-18Drug Facts
2022-07-29Drug Facts
2020-11-18Drug Facts
2020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0098-26GavisconExtra Strength100 in 1 BOTTLETABLET, CHEWABLE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0098-26EA - Each0135-009898dfc34c-1e3e-43c6-89da-0be8440a0c6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MAGNESIUM TRISILICATEACTIVE INGREDIENTC2E1CI501TGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SORBITOLINACTIVE INGREDIENT506T60A25RGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SUCROSEINACTIVE INGREDIENTC151H8M554GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0098GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 1 package rows20250516_7f367927-c366-465c-a059-e2cfb337d562.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 7 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratories78f11b4b-d203-45c9-9b29-2c135eb666192026-04-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
application number: M001
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
application number: M001
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
application number: M001
Dulcolax Soft Chews Mixed BerryMAGNESIUM HYDROXIDEChattem, Inc.fe71907c-b1eb-4433-9337-933a944f3e622026-03-31WarningsExact identifier
application number: M001
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
application number: M001
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
application number: M001
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
application number: M001
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN7f367927-c366-465c-a059-e2cfb337d56217
212978Gaviscon Extra Strength 160 MG / 105 MG Chewable TabletPSN7f367927-c366-465c-a059-e2cfb337d56217
212978aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable Tablet [Gaviscon]SBD7f367927-c366-465c-a059-e2cfb337d56217
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD7f367927-c366-465c-a059-e2cfb337d56217
212978Gaviscon Extra Strength (aluminum hydroxide 160 MG / magnesium carbonate 105 MG) Chewable TabletSY7f367927-c366-465c-a059-e2cfb337d56217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0135-0098-2600135009826100 TABLET, CHEWABLE in 1 BOTTLE (0135-0098-26) 2011-06-130000-00-00NoNoCurrent