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  4. NDC Product Code: 70565-580 Sal De Uvas Picot

NDC 70565-580 Sal De Uvas Picot

Citric Acid Monohydrate And Sodium Bicarbonate Granule, Effervescent Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70565-580?
  5. Sal De Uvas Picot 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:
70565-580
Proprietary Name:
Sal De Uvas Picot
Non-Proprietary Name: [1]
Citric Acid Monohydrate And Sodium Bicarbonate
Substance Name: [2]
Citric Acid Monohydrate; Sodium Bicarbonate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Granule, Effervescent - A small particle or grain containing a medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the capability to release gas, resulting in effervescence.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Reckitt Benckiser Mexico, S.a. De C.v.
    Labeler Code:
    70565
    Product Label ID:
    2d4e9346-7011-4595-afd1-bae9d8651ea2
    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]
    03-31-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Code Structure Chart

    Product Details

    What is NDC 70565-580?

    The NDC code 70565-580 is assigned by the FDA to the product Sal De Uvas Picot which is a human over the counter drug product labeled by Reckitt Benckiser Mexico, S.a. De C.v.. The generic name of Sal De Uvas Picot is citric acid monohydrate and sodium bicarbonate. The product's dosage form is granule, effervescent and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 70565-580-01 6 packet in 1 carton / 1 granule, effervescent in 1 packet, 70565-580-02 8 packet in 1 carton / 1 granule, effervescent in 1 packet, 70565-580-03 12 packet in 1 carton / 1 granule, effervescent in 1 packet, 70565-580-04 50 packet in 1 carton / 1 granule, effervescent in 1 packet. 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 Sal De Uvas Picot?

    Fully dissolve one packet in ½ glass of water every 4 hours or as directed by a doctoradults 60 years of age and over: do not exceed 3 packets in 24 hoursadults and children 12 to 60 years of age: do not exceed 4 packets in 24 hourschildren under 12 years of age: ask a doctor

    What are Sal De Uvas Picot 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.
    • CITRIC ACID MONOHYDRATE 1.9485 g/1 - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
    • SODIUM BICARBONATE 2.485 g/1 - A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

    Which are Sal De Uvas Picot UNII Codes?

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

    Which are Sal De Uvas Picot 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 Sal De Uvas Picot?

    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: 1795948 - citric acid 1.949 GM / sodium bicarbonate 2.485 GM Powder for Oral Solution
    • RxCUI: 1795948 - citric acid 1949 MG / sodium bicarbonate 2485 MG Powder for Oral Solution
    • RxCUI: 1795948 - Citric Acid 1949 MG / NaHCO3 2485 MG Powder for Oral Solution
    • RxCUI: 1795950 - picot 1.949 GM / 2.485 GM Powder for Oral Solution
    • RxCUI: 1795950 - citric acid 1949 MG / sodium bicarbonate 2485 MG Powder for Oral Solution [Picot]

    Which are the Pharmacologic Classes for Sal De Uvas Picot?

    * 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".