FDA.reportPublic FDA data

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone

Product NDC
57237-316
11-digit product format
572370316
Labeler code
57237
Product ID
57237-316_ea8b3419-ff01-4c21-9308-74ff70433ca0
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M001.15
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-15
Substance
ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength
1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE1200 mg/30mL
DIMETHICONE120 mg/30mL
MAGNESIUM HYDROXIDE1200 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 5QB0T2IUN0, NBZ3QY004S
Rxcui237870, 307746

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN982129d4-3cbf-4793-a861-d6c8f34bedc33
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN982129d4-3cbf-4793-a861-d6c8f34bedc33
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD982129d4-3cbf-4793-a861-d6c8f34bedc33
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD982129d4-3cbf-4793-a861-d6c8f34bedc33
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY982129d4-3cbf-4793-a861-d6c8f34bedc33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-316-035723703160330 mL in 1 CUP, UNIT-DOSE30 mlHistorical
57237-316-3157237031631100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-316-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-316-03) 2023-08-15NoNoCurrent