aluminum hydroxide, magnesium hydroxide and simethicone

Generic: aluminum hydroxide, magnesium hydroxide, and simethicone

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name aluminum hydroxide, magnesium hydroxide and simethicone
Generic Name aluminum hydroxide, magnesium hydroxide, and simethicone
Labeler rising pharma holdings, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

aluminum hydroxide 2400 mg/30mL, dimethicone 240 mg/30mL, magnesium hydroxide 2400 mg/30mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-324
Product ID 57237-324_ea8b3419-ff01-4c21-9308-74ff70433ca0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M001.15
Listing Expiration 2026-12-31
Marketing Start 2023-07-05

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237324
Hyphenated Format 57237-324

Supplemental Identifiers

RxCUI
237870 307746
UNII
5QB0T2IUN0 NBZ3QY004S 92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aluminum hydroxide, magnesium hydroxide and simethicone (source: ndc)
Generic Name aluminum hydroxide, magnesium hydroxide, and simethicone (source: ndc)
Application Number M001.15 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2400 mg/30mL
  • 240 mg/30mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-324-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-324-03)
source: ndc

Packages (1)

57237-324-31 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-324-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-324-03)

Ingredients (3)

aluminum hydroxide (2400 mg/30mL) dimethicone (240 mg/30mL) magnesium hydroxide (2400 mg/30mL)

Linked Drug Pages (1)

Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea8b3419-ff01-4c21-9308-74ff70433ca0", "openfda": {"nui": ["N0000010282"], "unii": ["5QB0T2IUN0", "NBZ3QY004S", "92RU3N3Y1O"], "rxcui": ["237870", "307746"], "spl_set_id": ["982129d4-3cbf-4793-a861-d6c8f34bedc3"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-324-31)  / 30 mL in 1 CUP, UNIT-DOSE (57237-324-03)", "package_ndc": "57237-324-31", "marketing_start_date": "20230705"}], "brand_name": "Aluminum Hydroxide, Magnesium Hydroxide and Simethicone", "product_id": "57237-324_ea8b3419-ff01-4c21-9308-74ff70433ca0", "dosage_form": "SUSPENSION", "pharm_class": ["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]"], "product_ndc": "57237-324", "generic_name": "Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aluminum Hydroxide, Magnesium Hydroxide and Simethicone", "active_ingredients": [{"name": "ALUMINUM HYDROXIDE", "strength": "2400 mg/30mL"}, {"name": "DIMETHICONE", "strength": "240 mg/30mL"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "2400 mg/30mL"}], "application_number": "M001.15", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230705", "listing_expiration_date": "20261231"}