Zicam Cold Remedy
Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed
Church & Dwight Co., Inc.
Human Otc Drug
NDC 10237-474Zicam Cold Remedy also known as Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed is a human otc drug labeled by 'Church & Dwight Co., Inc.'. National Drug Code (NDC) number for Zicam Cold Remedy is 10237-474. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Zicam Cold Remedy drug includes Galphimia Glauca Flowering Top - 4 [hp_X]/.56mL Luffa Operculata Fruit - 4 [hp_X]/.56mL Schoenocaulon Officinale Seed - 4 [hp_X]/.56mL . The currest status of Zicam Cold Remedy drug is Active.
Drug Information:
| Drug NDC: | 10237-474 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Zicam Cold Remedy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Church & Dwight Co., Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | GALPHIMIA GLAUCA FLOWERING TOP - 4 [hp_X]/.56mL
LUFFA OPERCULATA FRUIT - 4 [hp_X]/.56mL
SCHOENOCAULON OFFICINALE SEED - 4 [hp_X]/.56mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | NASAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Church & Dwight Co., Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0732216301083
|
| UPC stands for Universal Product Code. |
| UNII: | 93PH5Q8M7E
C4MO6809HU
6NAF1689IO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 10237-474-15 | 1 BOTTLE, PLASTIC in 1 CARTON (10237-474-15) / 15 mL in 1 BOTTLE, PLASTIC | 10 Apr, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose reduces duration of the common cold and helps relieve nasal congestion
Product Elements:
Zicam cold remedy galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed benzalkonium chloride sodium phosphate, dibasic, unspecified form eucalyptol eugenol glycine hypromellose, unspecified menthol, unspecified form sodium phosphate, monobasic, unspecified form phenylethyl alcohol polysorbate 80 water saccharin sodium sodium chloride succinic acid galphimia glauca flowering top galphimia glauca flowering top luffa operculata fruit luffa operculata fruit schoenocaulon officinale seed schoenocaulon officinale seed
Indications and Usage:
Uses reduces duration of the common cold and helps relieve nasal congestion --------------------------------------------------------------------------------------------------- zicam ® cold remedy was not formulated to be effective for flu or allergies.
Warnings:
Warnings for nasal use only do not use if you have a sensitivity or allergy to any of the ingredients. if an allergic reaction occurs, stop use and seek medical help right away. ask a doctor before use if you have ear, nose, or throat sensitivity susceptibility to nosebleeds when using this product avoid contact with eyes. rinse right away with water if it gets in eyes and seek medical help right away. the use of this container by more than one person may spread infection temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur stop use and ask a doctor if symptoms get worse or last more than 7 days or are accompanied by fever redness or swelling is present new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for nasal use only do not use if you have a sensitivity or allergy to any of the ingredients. if an allergic reaction occurs, stop use and seek medical help right away. ask a doctor before use if you have ear, nose, or throat sensitivity susceptibility to nosebleeds when using this product avoid contact with eyes. rinse right away with water if it gets in eyes and seek medical help right away. the use of this container by more than one person may spread infection temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur stop use and ask a doctor if symptoms get worse or last more than 7 days or are accompanied by fever redness or swelling is present new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes. rinse right away with water if it gets in eyes and seek medical help right away. the use of this container by more than one person may spread infection temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
Dosage and Administration:
Directions for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: remove cap and safety clip hold with thumb at bottom of bottle and nozzle between your fingers before using the first time, prime pump by depressing several times place tip of nozzle just past nasal opening (approximately 1/8") lean your head backwards slightly pump 2 times into each nostril avoid inhaling deeply wipe away any excess dose every 3 hours, not to exceed 5 doses in one 24 hour period children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if symptoms get worse or last more than 7 days or are accompanied by fever redness or swelling is present new symptoms occur
Package Label Principal Display Panel:
Principal display panel - 15 ml bottle carton zicam ® cold remedy shortens colds take at the first the pre-cold ® medicine sign of a cold the only cold shortening nasal spray no drip nasal spray with cooling menthol & eucalyptus 0.50 fl oz (15 ml) zinc-free homeopathic zicam cold remedy no drip nasal spray.jpg
Further Questions:
Questions? comments? call 877-942-2626 toll free www.zicam.com