NDC 10237-472 Zicam Cold Remedy

Galphimia Glauca Flowering Top,Luffa Operculata Fruit,And Schoenocaulon Officinale Seed - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
10237-472
Proprietary Name:
Zicam Cold Remedy
Non-Proprietary Name: [1]
Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed
Substance Name: [2]
Galphimia Glauca Flowering Top; Luffa Operculata Fruit; Schoenocaulon Officinale Seed
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
  • Labeler Name: [5]
    Church & Dwight Co., Inc.
    Labeler Code:
    10237
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    02-28-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 10237-472-20

    Package Description: 20 TUBE, WITH APPLICATOR in 1 CARTON / 1.2 mL in 1 TUBE, WITH APPLICATOR

    Product Details

    What is NDC 10237-472?

    The NDC code 10237-472 is assigned by the FDA to the product Zicam Cold Remedy which is a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Zicam Cold Remedy is galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed. The product's dosage form is gel and is administered via nasal form. The product is distributed in a single package with assigned NDC code 10237-472-20 20 tube, with applicator in 1 carton / 1.2 ml in 1 tube, with applicator. 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 Zicam Cold Remedy?

    For best results, use at the first sign of a cold and continue to use until symptoms completely subsideadults and children 12 years of age and older: open tube (also see illustration on side of carton)hold tube between thumb and forefinger at the blue bandwith other hand, hold at handle base, snap open tube and pull out swabapply medication just inside first nostril. Using swirling motion, rotate swab 3 times within nostril. While swirling, gently press outside of first nostril to ensure transfer of medication. Re-dip swab in tube and mix to re-saturate with medication. Swirl 3 more times in the same nostril while gently pressing outside of nostril. Re-dip swab in tube and mix. Repeat identical sequence in second nostril. Do not insert swab more than 1/4" past nasal opening.discard swab after usewait at least 30 seconds before blowing noseuse 1 tube every 3 hours, not to exceed 5 tubes in one 24 hour periodchildren under 12 years of age: do not use

    What are Zicam Cold Remedy 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 Zicam Cold Remedy UNII Codes?

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

    • GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E)
    • GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (Active Moiety)
    • LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU)
    • LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (Active Moiety)
    • SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO)
    • SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (Active Moiety)

    Which are Zicam Cold Remedy 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:

    * 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.

    [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".