Zicam Cold Remedy Gel
NDC 10237-472

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 10237-472?
  4. Zicam Cold Remedy Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Zicam Cold Remedy (galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Church & Dwight Co., Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gel for nasal administration. This product entry covers the primary NDC 10237-472 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Church & Dwight Co., Inc.
Labeler Code:
10237
Product Label ID:
d91738e5-1d2e-41d1-e053-2995a90a7aad
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
02-28-2022
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 10237-472?

The NDC code 10237-472 is assigned by the FDA to the product Zicam Cold Remedy. It is commonly known by its generic name, galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed. This pharmaceutical product is labeled by Church & Dwight Co., Inc. and is currently categorized as listed product. The medication is a gel administered via nasal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 10237-472-20, 10237-472-22. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated 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 the Inactive Ingredients associated 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:

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".