Zicam Allergy Relief

Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur


Matrixx Initiatives, Inc.
Human Otc Drug
NDC 62750-001
Zicam Allergy Relief also known as Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur is a human otc drug labeled by 'Matrixx Initiatives, Inc.'. National Drug Code (NDC) number for Zicam Allergy Relief is 62750-001. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Zicam Allergy Relief drug includes Galphimia Glauca Flowering Top - 30 [hp_X]/mL Histamine Dihydrochloride - 200 [hp_X]/mL Luffa Operculata Fruit - 30 [hp_X]/mL Sulfur - 200 [hp_X]/mL . The currest status of Zicam Allergy Relief drug is Active.

Drug Information:

Drug NDC: 62750-001
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 Allergy Relief
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, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Matrixx Initiatives, 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 - 30 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE - 200 [hp_X]/mL
LUFFA OPERCULATA FRUIT - 30 [hp_X]/mL
SULFUR - 200 [hp_X]/mL
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: 14 Apr, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 31 Oct, 2023
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: 10 Jun, 2026
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:Matrixx Initiatives, 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.
UNII:93PH5Q8M7E
3POA0Q644U
C4MO6809HU
70FD1KFU70
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
62750-001-111 BOTTLE, PLASTIC in 1 CARTON (62750-001-11) / 15 mL in 1 BOTTLE, PLASTIC14 Apr, 200031 Oct, 2023No
62750-001-121 BOTTLE, PLASTIC in 1 CARTON (62750-001-12) / 30 mL in 1 BOTTLE, PLASTIC14 Apr, 200031 Oct, 2023No
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 upper respiratory allergy symptom relief

Product Elements:

Zicam allergy relief galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur galphimia glauca flowering top galphimia glauca flowering top histamine dihydrochloride histamine luffa operculata fruit luffa operculata fruit sulfur sulfur benzalkonium chloride benzyl alcohol edetate disodium glycerin hydroxyethyl cellulose (100 mpa.s at 2%) potassium chloride potassium phosphate, unspecified form water sodium chloride sodium phosphate

Indications and Usage:

Uses temporarily relieves symptoms due to hay fever or other upper respiratory allergies such as: sinus pressure itchy, runny nose sneezing itchy, watery eyes nasal congestion

Warnings:

Warnings for nasal use only. ask a doctor before use if you have ear, nose, or throat sensitivity susceptibility to nosebleeds breathing problems such as emphysema or chronic bronchitis 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 persist or are accompanied by fever 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 adults and children 12 years of age and older: remove cap and safety clip (also see illustrations on side of carton) 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") while inside nasal opening, slightly angle nozzle outward pump once into each nostril after application, press lightly on outside of each nostril for about 5 seconds wait at least 30 seconds before blowing nose use once every 4 hours optimal results may not be seen for 1-2 weeks. after 1-2 weeks, you may need to use only 1-2 times daily. for best results, use up to 1 week before contact with known causes of your allergies. children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if symptoms persist or are accompanied by fever

Package Label Principal Display Panel:

Principal display panel - 15 ml bottle carton ndc 62750-001-11 zicam ® powerful allergy relief homeopathic • #1 • allergy brand* no-drip liquid ® nasal spray effective non-drowsy relief of: runny nose watery eyes itchy nose sneezing no known allergy drug interactions 0.50 fl oz (15 ml) homeopathic principal display panel - 15 ml bottle carton

Further Questions:

Questions? comments? side effects? call 877-942-2626 toll free


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.