NDC 11523-0034 Afrin Nodrip Allergy Sinus Night

Oxymetazoline Hydrochloride

NDC Product Code 11523-0034

NDC 11523-0034-1

Package Description: 15 mL in 1 BOTTLE

NDC Product Information

Afrin Nodrip Allergy Sinus Night with NDC 11523-0034 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Afrin Nodrip Allergy Sinus Night is oxymetazoline hydrochloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Bayer Healthcare Llc.

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.

Afrin Nodrip Allergy Sinus Night 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.

  • OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL

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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • WATER (UNII: 059QF0KO0R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • POVIDONE (UNII: FZ989GH94E)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • HIBISCUS BIFURCATUS WHOLE (UNII: 60F5JKG79P)

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.
  • 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: Bayer Healthcare Llc.
Labeler Code: 11523
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-09-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Afrin Nodrip Allergy Sinus Night Product Label Images

Afrin Nodrip Allergy Sinus Night 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient Purpose Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

Indications & Usage

Uses▪ temporarily relieves nasal congestion due to:▪ common cold ▪hay fever▪ upper respiratory allergies▪ reduces swelling of nasal passages so you can breathe more freely▪ temporarily relieves sinus congestion and pressure

Warnings

Warnings

Otc - Ask Doctor

▪ Ask a doctor before use if you have▪ heart disease • high blood pressure▪ thyroid disease ▪ diabetes▪ trouble urinating due to an enlarged prostate gland

Otc - When Using

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 torecur or worsen.▪ temporary discomfort such as burning, stinging, sneezing, or anincrease in nasal discharge may occur▪ use of this container by more than one person may spreadinfection

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.

Dosage & Administration

Directions▪ adults and children 6 to under 12 years of age (with adultsupervision): 2 or 3 sprays in each nostril not more often thanevery 10 to 12 hours. Do not exceed 2 doses in any 24-hourperiod.▪ children under 6 years of age: ask a doctorTo Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, 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. Secure cap after use.

Other Safety Information

Other information▪ store between 20º to 25ºC (68º to 77ºF)▪ retain carton for future reference on full labeling

Inactive Ingredient

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Otc - Questions

Questions or comments? 1-800-317-2165

Carton Label 15 Ml

Oxymetazoline HClNasal Solution-Nasal DecongestantAFRINNODRIPWont drive from nose or down throatAllergy SinusNightwith soothing chamomile scentPUMP MISTInstant Congestion Relief from Allergies for a More Restful NightReducesSwelling ofNasal Passages1/2 FL OZ (15mL)

* Please review the disclaimer below.