NDC 11523-1350 Afrin No Drip Severe Congestion
Oxymetazoline Hydrochloride Spray, Metered Nasal

Product Information

Product Code11523-1350
Proprietary Name 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.
Afrin No Drip Severe Congestion
Non-Proprietary Name 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.
Oxymetazoline Hydrochloride
Product Type 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.
Human Otc Drug
Dosage FormSpray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
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.
Bayer Healthcare Llc
Labeler Code11523
FDA Application Number What 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.
part341
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-31-2000
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 11523-1350-1

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

NDC 11523-1350-2

Package Description: 2 BOTTLE, PUMP in 1 CARTON > 20 mL in 1 BOTTLE, PUMP

Product Details

Afrin No Drip Severe Congestion is a human over the counter drug product labeled by Bayer Healthcare Llc. The generic name of Afrin No Drip Severe Congestion is oxymetazoline hydrochloride. The product's dosage form is spray, metered and is administered via nasal form.


What are Afrin No Drip Severe Congestion Active Ingredients?

The following is the list of active ingredients in 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.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


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)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • MENTHOL (UNII: L7T10EIP3A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


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Patient Education

Oxymetazoline Nasal Spray

Oxymetazoline Nasal Spray is pronounced as (ok'' see met az' oh leen)

Why is oxymetazoline nasal spray medication prescribed?
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymeta...
[Read More]

* Please review the disclaimer below.

Afrin No Drip Severe Congestion Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Bayer HealthCare LLC, Whippany, NJ, USA, 07981


Active Ingredient



Oxymetazoline hydrochloride 0.05%


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
    • shrinks swollen nasal membranes so you can breathe more freely

Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When Using This Product



  • do not use more than directed
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Otc - Stop Use



Stop use and ask 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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor.
  • Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.


Other Information



  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredients



benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic


Questions Or Comments?



Call 1-800-317-2165


* Please review the disclaimer below.