FDA.reportPublic FDA data

Inon Ace

Product NDC
49873-403
11-digit product format
498730403
Labeler code
49873
Product ID
49873-403_0bde7bd2-8a69-57b4-e063-6394a90a00d2
Type
HUMAN OTC DRUG
Nonproprietary name
magnesium aluminosilicate, magnesium hydroxide
Dosage form
SOLUTION
Route
ORAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-05-20
Substance
SILODRATE; MAGNESIUM HYDROXIDE
Active strength
900; 250 mg/30mL; mg/30mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 Ace
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILODRATE900 mg/30mL
MAGNESIUM HYDROXIDE250 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9T3UU8T0QKInternal UNII lookup
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246297Internal RxNorm lookup
1246303Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6e4475c-dfac-493c-b98a-21473e3b59d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-403-01Inon Ace2 in 1 CARTONSOLUTION27
49873-403-01Inon Ace30 mL in 1 BOTTLESOLUTION307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
SILODRATEACTIVE INGREDIENT9T3UU8T0QKINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838INON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
SILODRATEACTIVE MOIETY9T3UU8T0QKINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8INON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)INACTIVE INGREDIENT9M44R3409AINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
SORBITOLINACTIVE INGREDIENT506T60A25RINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RINON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-403INON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231207_a6e4475c-dfac-493c-b98a-21473e3b59d5.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 32 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001
ndc (product): 49873-403
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
application number: M001
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
application number: M001
GERI-LANTA SUPREME CHERRYCALCIUM CARBONATE, MAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp7fbc654b-a0d4-408c-bb5a-eb50b7b543822023-11-08WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246297aluminum magnesium silicate 900 MG / magnesium hydroxide 250 MG in 30 mL Oral SolutionPSNa6e4475c-dfac-493c-b98a-21473e3b59d57
1246303Inon Ace 900 MG / 250 MG in 30 mL Oral SolutionPSNa6e4475c-dfac-493c-b98a-21473e3b59d57
1246303aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML Oral Solution [Inon Ace Solution]SBDa6e4475c-dfac-493c-b98a-21473e3b59d57
1246297aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML Oral SolutionSCDa6e4475c-dfac-493c-b98a-21473e3b59d57
1246303Inon Ace Solution (aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML) Oral SolutionSYa6e4475c-dfac-493c-b98a-21473e3b59d57
1246303Inon Ace Solution (aluminum magnesium silicate 900 MG / magnesium hydroxide 250 MG) per 30 ML Oral SolutionSYa6e4475c-dfac-493c-b98a-21473e3b59d57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-403-01498730403012 BOTTLE in 1 CARTON (49873-403-01) / 30 mL in 1 BOTTLE2 bottle2000-05-200000-00-00NoNoCurrent