NDC 37808-554 Antacid

Aluminum Hydroxide,Magnesium Hydroxide,Simethicone Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
37808-554
Proprietary Name:
Antacid
Non-Proprietary Name: [1]
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Substance Name: [2]
Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    H E B
    Labeler Code:
    37808
    FDA Application Number: [6]
    part331
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    12-13-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Product Packages

    NDC Code 37808-554-05

    Package Description: 355 mL in 1 BOTTLE

    Product Details

    What is NDC 37808-554?

    The NDC code 37808-554 is assigned by the FDA to the product Antacid which is a human over the counter drug product labeled by H E B. The generic name of Antacid is aluminum hydroxide, magnesium hydroxide, simethicone. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 37808-554-05 355 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Antacid?

    This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

    What are Antacid Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Antacid UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Antacid Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Antacid?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 307746 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension
    • RxCUI: 307746 - aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension
    • RxCUI: 307746 - aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension
    • RxCUI: 307746 - aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension
    • RxCUI: 307746 - aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension

    Which are the Pharmacologic Classes for Antacid?

    * Please review the disclaimer below.

    Patient Education

    Aluminum Hydroxide and Magnesium Hydroxide


    Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    Simethicone


    Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".