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 41 of 57 · 1,127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
unii: 92RU3N3Y1O
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
unii: 92RU3N3Y1O
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
unii: 92RU3N3Y1O
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: Z8IX2SC1OH
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATIONd2f8dcc2-8833-4426-9c12-1a60871451222024-10-30WarningsExact identifier
unii: 5QB0T2IUN0
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATION9889cf9e-3f6a-4abc-b723-0b295c7c8f932024-10-30WarningsExact identifier
unii: 5QB0T2IUN0
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Extra Strength Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEPHARMACY VALUE ALLIANCE, LLCe33db45a-594e-4af8-ab16-10010fc8a3882024-10-25WarningsExact identifier
unii: 5QB0T2IUN0
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
unii: NBZ3QY004S
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
unii: 92RU3N3Y1O
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
unii: NBZ3QY004S
unii: 92RU3N3Y1O
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
unii: 92RU3N3Y1O
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
unii: 92RU3N3Y1O
SILICEA COMPLEX IIECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI CHLORICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUM, SILICONE (DIMETHICONE).BioActive Nutritional, Inc.df277f21-9e60-4c64-928a-b1d9251032822024-10-18WarningsExact identifier
unii: 92RU3N3Y1O
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
unii: 92RU3N3Y1O
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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