NDC 36800-458 Topcare All Day Allergy

Cetirizine Hydrochloride Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
36800-458
Proprietary Name:
Topcare All Day Allergy
Non-Proprietary Name: [1]
Cetirizine Hydrochloride
Substance Name: [2]
Cetirizine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Topco Associates Llc
    Labeler Code:
    36800
    FDA Application Number: [6]
    ANDA078336
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-10-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    OVAL (C48345)
    Size(s):
    10 MM
    Imprint(s):
    4H2
    Score:
    1

    Product Packages

    NDC Code 36800-458-06

    Package Description: 1 BOTTLE in 1 CARTON / 70 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.08054 per EA

    NDC Code 36800-458-39

    Package Description: 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.08054 per EA

    NDC Code 36800-458-47

    Package Description: 1 BOTTLE in 1 CARTON / 150 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.08054 per EA

    NDC Code 36800-458-58

    Package Description: 1 BOTTLE in 1 CARTON / 40 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 36800-458-66

    Package Description: 14 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

    Price per Unit: $0.08054 per EA

    NDC Code 36800-458-72

    Package Description: 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.06418 per EA

    NDC Code 36800-458-75

    Package Description: 1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 36800-458-87

    Package Description: 1 BOTTLE in 1 CARTON / 300 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.08054 per EA

    NDC Code 36800-458-95

    Package Description: 1 BOTTLE in 1 CARTON / 45 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.08054 per EA

    Product Details

    What is NDC 36800-458?

    The NDC code 36800-458 is assigned by the FDA to the product Topcare All Day Allergy which is a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare All Day Allergy is cetirizine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 9 packages with assigned NDC codes 36800-458-06 1 bottle in 1 carton / 70 tablet, film coated in 1 bottle, 36800-458-39 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle, 36800-458-47 1 bottle in 1 carton / 150 tablet, film coated in 1 bottle, 36800-458-58 1 bottle in 1 carton / 40 tablet, film coated in 1 bottle, 36800-458-66 14 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack, 36800-458-72 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle, 36800-458-75 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle, 36800-458-87 1 bottle in 1 carton / 300 tablet, film coated in 1 bottle, 36800-458-95 1 bottle in 1 carton / 45 tablet, film coated 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 Topcare All Day Allergy?

    Adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.adults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

    What are Topcare All Day Allergy 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 Topcare All Day Allergy UNII Codes?

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

    Which are Topcare All Day Allergy 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 Topcare All Day Allergy?

    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:

    Which are the Pharmacologic Classes for Topcare All Day Allergy?

    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.

    Patient Education

    Cetirizine Injection


    Cetirizine injection is used to treat acute urticaria in adults and children 6 months of age or older. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [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".