FDA.reportPublic FDA data

NDC 57237-316-03 - 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
57237-316
Requested NDC
57237-316-03
Package NDCs from labels
57237-316-03, 57237-316-31
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
57237-316-03Aluminum Hydroxide, Magnesium Hydroxide and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION303
57237-316-31Aluminum Hydroxide, Magnesium Hydroxide and Simethicone100 in 1 BOX, UNIT-DOSESUSPENSION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-316ALUMINUM 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
57237-316-03ML - Milliliter57237-3168d8f9c7b-c4d9-42ba-94c4-161057268f0412023-09-05
57237-316-31ML - Milliliter57237-3163cab9d8d-c9b9-4017-9d23-a14f66fe386912023-09-05

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 31 of 57 · 1,127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsExact identifier
unii: 92RU3N3Y1O
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Phillips Milk Of Magnesia Wild CherryPHILLIPS MILK OF MAGNESIA WILD CHERRYBayer HealthCare LLC.0a6d824a-3d9a-07f9-e054-00144ff8d46c2025-04-01WarningsExact identifier
unii: NBZ3QY004S
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
rxcui: 307746
unii: 5QB0T2IUN0
unii: NBZ3QY004S
unii: 92RU3N3Y1O
Dulcolax Chewy Fruit Bites Cherry BerryMAGNESIUM HYDROXIDEChattem, Inc.b29d2771-f685-45c5-b18b-3ca976df69842025-03-31WarningsExact identifier
unii: NBZ3QY004S
Signature Care Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway249b19fd-d5b3-4c93-92bb-f277797015b42025-03-27WarningsExact identifier
unii: NBZ3QY004S
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Max Gas Antacid plus Anti-Gas ChewsSIMETHICONETopCo309e8215-84b0-dd84-e063-6394a90ac4422025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Cherry Berry Lime Antacid HBGCALCIUM CARBONATETopCo30a01bf6-28c8-87ae-e063-6394a90a6fb52025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra Strength SoftgelsSIMETHICONEHaleon US Holdings LLCfa4a3b07-591b-4445-aa67-b17ba1e67d5c2025-03-14WarningsExact identifier
unii: 92RU3N3Y1O
Supreme AntacidCALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E B18a7dfd9-d927-7625-e063-6394a90a270f2025-03-14WarningsExact identifier
unii: NBZ3QY004S
CVS Magnesium Hydroxide Laxative ChewMAGNESIUM HYDROXIDECVS30126c74-6f5c-72f3-e063-6394a90ad81f2025-03-11WarningsExact identifier
unii: NBZ3QY004S
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Supreme AntacidCALCIUM CARBONATE, MAGNESIUM HYDROXIDEDiscount Drug Mart, Inc2e0b175c-2cc8-b18a-e063-6394a90a028e2025-02-27WarningsExact identifier
unii: NBZ3QY004S
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
unii: 92RU3N3Y1O
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDEDiscount Drug Mart, Inc2e0a1913-c3d4-7c7d-e063-6294a90a48412025-02-26WarningsExact identifier
unii: NBZ3QY004S

Reported adverse events (FAERS/openFDA)#

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