FDA.reportPublic FDA data

Gaviscon

Product NDC
0135-0430
11-digit product format
001350430
Labeler code
0135
Product ID
0135-0430_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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 38 · 742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpe62f6f6f-59a9-4df4-91ca-a76c4de93fe02026-07-15WarningsExact 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
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0430-032025-02-01C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032023-04-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032022-07-29C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032020-11-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032020-01-31C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0430-03GavisconExtra Strength100 in 1 BOTTLETABLET, CHEWABLE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0430-03EA - Each0135-0430909107f4-1ed7-4afe-a965-cdc166c28a1c12012-07-24

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
0135-0430GAVISCON 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

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
0135-0430-0300135043003100 TABLET, CHEWABLE in 1 BOTTLE (0135-0430-03) 2011-06-130000-00-00NoNoCurrent