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  4. NDC Product Code: 69423-825 Rolaids Ultra Strength Antacid Assorted Fruit

NDC 69423-825 Rolaids Ultra Strength Antacid Assorted Fruit

Calcium Carbonate,Magnesium Hydroxide Tablet, Chewable Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69423-825?
  5. Rolaids Ultra Strength Antacid Assorted Fruit 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:
69423-825
Proprietary Name:
Rolaids Ultra Strength Antacid Assorted Fruit
Non-Proprietary Name: [1]
Calcium Carbonate, Magnesium Hydroxide
Substance Name: [2]
Calcium Carbonate; Magnesium Hydroxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    The Procter & Gamble Manufacturing Company
    Labeler Code:
    69423
    Product Label ID:
    0cc9d823-bdac-0a65-e063-6394a90aa65c
    FDA Application Number: [6]
    M001
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-01-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    YELLOW (C48330)
    ORANGE (C48331)
    Shape:
    ROUND (C48348)
    Size(s):
    19 MM
    Imprint(s):
    R;U
    Score:
    1
    Flavor(s):
    FRUIT (C73389 - CHERRY, LEMON, ORANGE)

    Code Structure Chart

    Product Details

    What is NDC 69423-825?

    The NDC code 69423-825 is assigned by the FDA to the product Rolaids Ultra Strength Antacid Assorted Fruit which is a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Rolaids Ultra Strength Antacid Assorted Fruit is calcium carbonate, magnesium hydroxide. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 69423-825-10 10 tablet, chewable in 1 package , 69423-825-72 72 tablet, chewable in 1 bottle, plastic . 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 Rolaids Ultra Strength Antacid Assorted Fruit?

    Chew 2-3 tablets as symptoms occur, or as directed by a doctor

    What are Rolaids Ultra Strength Antacid Assorted Fruit 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 1000 mg/1 - 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.
    • MAGNESIUM HYDROXIDE 200 mg/1 - An inorganic compound that occurs in nature as the mineral brucite. It acts as an antacid with cathartic effects.

    Which are Rolaids Ultra Strength Antacid Assorted Fruit UNII Codes?

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

    Which are Rolaids Ultra Strength Antacid Assorted Fruit 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 Rolaids Ultra Strength Antacid Assorted Fruit?

    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: 1438105 - calcium carbonate 1000 MG / magnesium hydroxide 200 MG Chewable Tablet
    • RxCUI: 1438107 - Rolaids ULTRA 1000 MG / 200 MG Chewable Tablet, Reformulated Aug 2006
    • RxCUI: 1438107 - calcium carbonate 1000 MG / magnesium hydroxide 200 MG Chewable Tablet [Rolaids Reformulated Aug 2006]
    • RxCUI: 1438107 - Rolaids Ultra (calcium carbonate 10000 MG / magnesium hydroxide 200 MG) Chewable Tablet, Reformulated Aug 2006

    Which are the Pharmacologic Classes for Rolaids Ultra Strength Antacid Assorted Fruit?

    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".