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 13 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.84771ac5-ad0b-e0ec-e053-2a91aa0a1b362025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.bdb43d3b-ddcd-4359-a174-a5556e7c5f572025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.7857c357-38cb-2f61-e053-2991aa0a66022025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
application number: M001
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
application number: M001
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
application number: M001
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
application number: M001
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
application number: M001
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
application number: M001
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
application number: M001
Quality Choice Ultra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION63318b46-d47d-474c-8fb5-5e0d53b7adb42025-12-03WarningsExact identifier
application number: M001
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.8064b01a-e049-4d49-a5b6-e72dbeb5daac2025-12-03WarningsExact identifier
application number: M001
calcium antacidextra strength extra strengthCALCIUM CARBONATERugby Laboratoriesd761954f-940e-4833-87b7-173a921aade12025-12-03WarningsExact 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