FDA.reportPublic FDA data

NDC 57237-324-03 - Aluminum Hydroxide, Magnesium Hydroxide and Simethicone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57237-324
Requested NDC
57237-324-03
Package NDCs from labels
57237-324-03, 57237-324-31
Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2025-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALUMINUM HYDROXIDE - Rising Pharma Holdings, Inc.Rising Pharma Holdings, Inc.2025-07-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-324-03Aluminum Hydroxide, Magnesium Hydroxide and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION303
57237-324-31Aluminum Hydroxide, Magnesium Hydroxide and Simethicone100 in 1 BOX, UNIT-DOSESUSPENSION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-324ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE) SUSPENSION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241019_982129d4-3cbf-4793-a861-d6c8f34bedc3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-324-03ML - Milliliter57237-32467148dfe-350b-4a69-8720-f8be5415fb4012023-10-16
57237-324-31ML - Milliliter57237-324c1967d33-659d-4a98-8698-0a7cea113f7412023-10-16

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 29 of 57 · 1,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
rxcui: 307746
unii: 5QB0T2IUN0
unii: NBZ3QY004S
unii: 92RU3N3Y1O
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leader6a492dd2-61f1-4020-bebd-fcc8e56472072025-07-08WarningsExact identifier
unii: NBZ3QY004S
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEKroger Companybf2fcb88-418f-4d5d-85ba-ec165a53ab042025-07-07WarningsExact identifier
unii: NBZ3QY004S
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWal-Mart Stores Inccb683c1c-db81-40a9-9ec5-f8dfa0dcf8122025-07-07WarningsExact identifier
unii: NBZ3QY004S
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
rxcui: 307746
unii: 5QB0T2IUN0
unii: NBZ3QY004S
unii: 92RU3N3Y1O
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E Bea712fc4-7f27-4556-b1b8-028f3f6ce57a2025-07-07WarningsExact identifier
unii: NBZ3QY004S
DG Health acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEDolgencorp, LLC95c2c515-0f31-49d9-b799-7aaded81a37c2025-07-07WarningsExact identifier
unii: NBZ3QY004S
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
unii: 92RU3N3Y1O
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETopco Associates LLC8ef70327-9a04-413b-b331-f5d3a94d6b362025-07-01WarningsExact identifier
unii: NBZ3QY004S
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
unii: 92RU3N3Y1O
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWalgreen Company3a456dab-0a2d-4e48-a8e2-e49a7acef9632025-07-01WarningsExact identifier
unii: NBZ3QY004S
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEH E Bc1aa7efa-4be1-4c8f-8994-661dd60e1aa92025-07-01WarningsExact identifier
unii: NBZ3QY004S
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leadera5420ef1-313f-4561-baf1-7ae017ea343a2025-07-01WarningsExact identifier
unii: NBZ3QY004S
Milk of MagnesiaMAGNESIUM HYDROXIDERising Pharma Holdings, Inc.dfede6bd-df37-4f0f-9944-49dc13c967de2025-07-01WarningsExact identifier
unii: NBZ3QY004S
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONERising Pharma Holdings, Inc.982129d4-3cbf-4793-a861-d6c8f34bedc32025-07-01WarningsExact identifier
ndc (package): 57237-316-31
ndc (package): 57237-324-31
ndc (package): 57237-316-03
ndc (package): 57237-324-03
ndc (product): 57237-324
ndc (product): 57237-316
ndc11 (package): 57237032403
rxcui: 237870
rxcui: 307746
spl id: ea8b3419-ff01-4c21-9308-74ff70433ca0
spl set id: 982129d4-3cbf-4793-a861-d6c8f34bedc3
unii: 5QB0T2IUN0
unii: NBZ3QY004S
unii: 92RU3N3Y1O
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
unii: 92RU3N3Y1O
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEMorning Star OTCbe7f97d5-d2f2-45a8-96b4-fed1549ae2a32025-06-19WarningsExact identifier
unii: NBZ3QY004S

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.