NDC 10237-463 Zicam Allergy Relief

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

NDC Product Code 10237-463

NDC CODE: 10237-463

Proprietary Name: Zicam Allergy Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur 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.

NDC Code Structure

  • 10237 - Church & Dwight Co., Inc.

NDC 10237-463-15

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Zicam Allergy Relief with NDC 10237-463 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Zicam Allergy Relief is galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur. The product's dosage form is spray and is administered via nasal form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug 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.

Zicam Allergy Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Church & Dwight Co., Inc.
Labeler Code: 10237
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 10-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Zicam Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Galphimia glauca 12x, 30x

Histaminum hydrochloricum 12x, 30x, 200x

Luffa operculata 4x, 12x, 30x

Sulphur 12x, 30x, 200x

Purpose

Upper respiratory allergy symptom relief

Uses

  • Effective Relief of Allergy Symptoms:
  • Runny noseitchy nosewatery eyessneezing

Warnings

For nasal use only.

Ask A Doctor Before Use If You Have

  • Ear, nose, or throat sensitivitysusceptibility to nosebleedsbreathing 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 infectionteamporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 fingersbefore using the first time, prime pump by depressing several timesplace tip of nozzle just past nasal opening (approximately 1/8")while inside nasal opening, slightly angle nozzle outwardpump once into each nostrilafter application, press lightly on outside of each nostril for about 5 secondswait at least 30 seconds before blowing noseuse once every 4 hoursoptimal 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

Other Information

  • Store between 15-29°C (59-84°F)

Inactive Ingredients

Benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, potassium chloride, potassium phosphate, purified water, sodium chloride, sodium phosphate

* Please review the disclaimer below.