NDC 67751-209 12 Hour Original Nasal Decongestant

Nasal Spray

NDC Product Code 67751-209

NDC 67751-209-01

Package Description: 1 BOTTLE, SPRAY in 1 PACKAGE > 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

12 Hour Original Nasal Decongestant with NDC 67751-209 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc.. The generic name of 12 Hour Original Nasal Decongestant is nasal spray. The product's dosage form is liquid and is administered via nasal form.

Labeler Name: Navajo Manufacturing Company Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

12 Hour Original Nasal Decongestant 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 50 mg/100mL

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.

  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • POVIDONE K29/32 (UNII: 390RMW2PEQ)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • WATER (UNII: 059QF0KO0R)

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: Navajo Manufacturing Company Inc.
Labeler Code: 67751
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: 12-10-2020 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.

12 Hour Original Nasal Decongestant Product Label Images

12 Hour Original 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

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal Decongestant

Uses

  • Tempoarily relieves nasal congestion due to:common coldhay feversinusitisupper respiratory allergiesShrinks swollen membranes so you can breathe more freely.

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart dieasehigh blood pressurediabetesthyiod dieasetrouble urinating due to enlarged rostate gland.

Otc - When Using

  • When using this productdo not use more than directeddo not use for more than three 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 - Keep Out Of Reach Of Children

If pregnant or breast-feeding, ask a health professional before use.
Keep out of the 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 than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.children under 6 years of age consult a doctorTo spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying. Wipe nozzle clean after use.

Other Information

  • Store at a controlled room temperature 20°-25°C (68°-77°F)keep card for future reference on full labeling

Inactive Ingredients

Benzalkonium Chloride, Disodium EDTA, Disodium Phosphate, Glycerin, PEG-6, Propylene Glycol, PVP, Sodium Phosphate, Water (Purified)

* Please review the disclaimer below.