NDC 0295-0100 Benzedrex Nasal Decongestant

Propylhexedrine

NDC Product Code 0295-0100

NDC Code: 0295-0100

Proprietary Name: Benzedrex Nasal Decongestant Additional informationCallout TooltipWhat 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: Propylhexedrine Additional informationCallout TooltipWhat 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.


Code Structure
  • 0295 - Denison Pharmaceuticals Llc
    • 0295-0100 - Benzedrex Nasal Decongestant

NDC 0295-0100-52

Package Description: 1 INHALANT in 1 INHALER

NDC Product Information

Benzedrex Nasal Decongestant with NDC 0295-0100 is a a human over the counter drug product labeled by Denison Pharmaceuticals Llc. The generic name of Benzedrex Nasal Decongestant is propylhexedrine. The product's dosage form is inhalant and is administered via nasal form.

Labeler Name: Denison Pharmaceuticals Llc

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Benzedrex Nasal Decongestant Active Ingredient(s)

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

  • PROPYLHEXEDRINE 250 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MENTHOL (UNII: L7T10EIP3A)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Denison Pharmaceuticals Llc
Labeler Code: 0295
FDA Application Number: part341 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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: 01-21-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Benzedrex Nasal Decongestant Product Label Images

Benzedrex Nasal Decongestant 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

Otc - Active Ingredient

Active ingredient................. Purpose




Propylhexedrine 250 mg......Nasal decongestant

Indications & Usage

UsesFor the temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Otc - Purpose

Uses
Temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Warnings

  • WarningsDo not exceed recommended dosage.This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.The use of this container by more than one person may spread infection.Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. Ill effects may result if taken internally

Otc - Do Not Use

Do not use this product for more than three days.

Otc - Ask Doctor

Stop use and consult a doctor if symptoms persist.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. In case of overdose or ingestion of contents, get medical help or contact a poison control center immediately.

Dosage & Administration

  • Directions adults and children 6 to 12 years of age (with adult supervision): two inhalations in each nostril not more than every two hours.children under 6 years of age: consult a doctor

Instructions For Use

  • Directions adults and children 6 to 12 years of age (with adult supervision): two inhalations in each nostril not more than every two hours.children under 6 years of age: consult a doctor

Storage And Handling

  • Other informationstore at 59°-86° F (15°-30° C)keep inhaler tightly closed mfd. in USA for B.F. Ascher & Co., Inc.this inhaler is effective for a minimum of 3 months after first use

Inactive Ingredient

Inactive ingredientslavender oil, menthol

Otc - Questions

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit us at



www.bfascher.com

* Please review the disclaimer below.

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