NDC 58809-389 Texaclear Pain Reliever

Caffeine,Choline Salicylate Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
58809-389
Proprietary Name:
Texaclear Pain Reliever
Non-Proprietary Name: [1]
Caffeine, Choline Salicylate
Substance Name: [2]
Caffeine; Choline Salicylate
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]
    Gm Pharmaceuticals, Inc
    Labeler Code:
    58809
    FDA Application Number: [6]
    part343
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    12-14-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 58809-389-08

    Package Description: 237 mL in 1 BOTTLE

    Product Details

    What is NDC 58809-389?

    The NDC code 58809-389 is assigned by the FDA to the product Texaclear Pain Reliever which is a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Texaclear Pain Reliever is caffeine, choline salicylate. 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 58809-389-08 237 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 Texaclear Pain Reliever?

    Do not take more than directed.adults and children 12 years of age and over: take 30mL every 6 hours, while symptoms persistdo not take exceed 4 doses in any 24 hours unless directed by a doctor children under 12 years of age: ask a doctor use enclosed dose cup

    What are Texaclear Pain Reliever 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.
    • CAFFEINE 65 mg/30mL - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
    • CHOLINE SALICYLATE 870 mg/30mL

    Which are Texaclear Pain Reliever UNII Codes?

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

    Which are Texaclear Pain Reliever 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 Texaclear Pain Reliever?

    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: 1994320 - caffeine 65 MG / choline salicylate 870 MG in 30 mL Oral Solution
    • RxCUI: 1994320 - caffeine 2.17 MG/ML / choline salicylate 29 MG/ML Oral Solution
    • RxCUI: 1994320 - caffeine 65 MG / choline salicylate 870 MG per 30 ML Oral Solution

    Which are the Pharmacologic Classes for Texaclear Pain Reliever?

    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".