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  4. NDC Product Code: 62372-410 Childrens Mylicon All In One Tummy Relief For Kids

NDC 62372-410 Childrens Mylicon All In One Tummy Relief For Kids

Antacid And Antigas Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 62372-410?
  5. Childrens Mylicon All In One Tummy Relief For Kids Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
62372-410
Proprietary Name:
Childrens Mylicon All In One Tummy Relief For Kids
Non-Proprietary Name: [1]
Antacid And Antigas
Substance Name: [2]
Calcium Carbonate; Dimethicone
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]
    Infirst Healthcare Inc.
    Labeler Code:
    62372
    Product Label ID:
    0952eba8-6de2-4a77-956d-339fab437472
    FDA Application Number: [6]
    M002
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    11-24-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Flavor(s):
    BUBBLE GUM (C73368)

    Product Packages

    NDC Code 62372-410-04

    Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

    Product Details

    What is NDC 62372-410?

    The NDC code 62372-410 is assigned by the FDA to the product Childrens Mylicon All In One Tummy Relief For Kids which is a human over the counter drug product labeled by Infirst Healthcare Inc.. The generic name of Childrens Mylicon All In One Tummy Relief For Kids is antacid and antigas. 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 62372-410-04 1 bottle in 1 carton / 120 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 Childrens Mylicon All In One Tummy Relief For Kids?

    •shake well before use •measure with dosing cup provided•follow directions based on age/weight below or as directed by a doctor•repeat as needed •do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor •clean dosing cup after use •mL = milliliterAge WeightDosage (mL)under 2 yrsunder 24 lbsask a doctor2-5 yrs24-47 lbs5 mL. Not more than 15 mL in 24 hours.6-11 yrs48-95 lbs10 mL. Not more than 30 mL in 24 hours.

    What are Childrens Mylicon All In One Tummy Relief For Kids 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.
    • CALCIUM CARBONATE 400 mg/5mL - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
    • DIMETHICONE 40 mg/5mL

    Which are Childrens Mylicon All In One Tummy Relief For Kids UNII Codes?

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

    Which are Childrens Mylicon All In One Tummy Relief For Kids 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 Childrens Mylicon All In One Tummy Relief For Kids?

    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: 2599608 - calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral Suspension
    • RxCUI: 2599608 - calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral Suspension
    • RxCUI: 2599612 - MYLICON Children's 400 MG / 40 MG in 5 mL Oral Suspension
    • RxCUI: 2599612 - calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mylicon Children's]
    • RxCUI: 2599612 - Mylicon Children's (calcium carbonate 400 MG / simethicone 40 MG per 5 ML) Oral Suspension

    Which are the Pharmacologic Classes for Childrens Mylicon All In One Tummy Relief For Kids?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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".