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 3 of 57 · 1,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
rxcui: 307746
unii: 5QB0T2IUN0
unii: NBZ3QY004S
unii: 92RU3N3Y1O
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
unii: 5QB0T2IUN0
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: NBZ3QY004S
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: NBZ3QY004S
unii: 92RU3N3Y1O
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
unii: NBZ3QY004S
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Extra Strength Heartburn Relief Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.5c32d90b-68a0-4acf-94b6-d02037cea3762026-08-13WarningsExact identifier
unii: 5QB0T2IUN0
CVS PHARMACY Extra Strength Cherry FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.cf7ae053-fa8d-4e6e-af4f-b846699aaf242026-08-13WarningsExact identifier
unii: 5QB0T2IUN0
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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