FDA.reportPublic FDA data

INON

Product NDC
49873-045
11-digit product format
498730045
Labeler code
49873
Product ID
49873-045_0bb8901e-89d2-b026-e063-6294a90ae77a
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium carbonate, sodium bicarbonate
Dosage form
GRANULE
Route
ORAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-05-31
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE; SODIUM BICARBONATE
Active strength
400; 400; 700 mg/1.92g; mg/1.92g; mg/1.92g
Pharmacologic classes
Alkalinizing Activity [MoA]
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
INON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/1.92g
MAGNESIUM CARBONATE400 mg/1.92g
SODIUM BICARBONATE700 mg/1.92g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
0E53J927NAInternal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e86d9c57-c877-49f1-a405-95a9a226ccf3Available 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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-045-01INON1.92 g in 1 PACKETGRANULE1.924
49873-045-01INON12 in 1 CARTONGRANULE124

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAINON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOINON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
bicarbonate ionACTIVE MOIETYHN1ZRA3Q20INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
carbonate ionACTIVE MOIETY7UJQ5OPE7DINON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TINON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1
SUCROSEINACTIVE INGREDIENTC151H8M554INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-045INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231205_e86d9c57-c877-49f1-a405-95a9a226ccf3.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 33 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
application number: M001
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEH E Babfe6688-f852-ba8e-e053-2995a90a49a32023-11-07WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGOODSENSEa9654a96-9bf9-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
ADVANCED ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa964da1d-e1e3-94a8-e053-2a95a90ac8042023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEKROGER COMPANYa1b132d5-00d0-55c1-e053-2a95a90a8d272023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e5fc3f-caf0-84c4-e053-2a95a90af6552023-11-07WarningsExact identifier
application number: M001
ANTACID PLUSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS LLCb8e233c7-eaa0-b1ec-e053-2a95a90a05492023-11-07WarningsExact identifier
application number: M001
Antacid PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS, LLCb93191e8-28a7-6c8f-e053-2995a90ac3272023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ADVANCED ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEDOLGENCORP, LLCb6993a5a-6144-ba65-e053-2995a90aee9b2023-11-07WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONb4656a2f-a866-5f7a-e053-2995a90ac2c22023-11-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association9f410b3a-5579-4fae-84b1-5cd35563451e2023-11-06WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association60de23d0-6e75-3b97-e053-2a91aa0aea5e2023-11-06WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
application number: M001
ALMACONE DOUBLE STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIES25f22cff-2864-4853-a7f8-8edd9f8f3c292023-11-02WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e8215a4-0136-bfdd-e053-2991aa0a5ddf2023-11-01WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e946ed2-819e-fb40-e053-2991aa0a6f772023-11-01WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-045-014987300450112 PACKET in 1 CARTON (49873-045-01) / 1.92 g in 1 PACKET12 packet1989-05-310000-00-00NoNoCurrent