Oxymethazoline Hcl


Proficient Rx Lp
Human Otc Drug
NDC 71205-383
Oxymethazoline Hcl is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Oxymethazoline Hcl is 71205-383. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Oxymethazoline Hcl drug includes Oxymetazoline Hydrochloride - .05 mg/1 . The currest status of Oxymethazoline Hcl drug is Active.

Drug Information:

Drug NDC: 71205-383
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Oxymethazoline Hcl
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Oxymethazoline Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Proficient Rx Lp
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Spray
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:OXYMETAZOLINE HYDROCHLORIDE - .05 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:NASAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 01 Jan, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part341
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Proficient Rx LP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
UPC:0371205383305
UPC stands for Universal Product Code.
UNII:K89MJ0S5VY
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Imidazolines [CS]
Increased Sympathetic Activity [PE]
Vasoconstriction [PE]
Vasoconstrictor [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
71205-383-301 BOTTLE, SPRAY in 1 CARTON (71205-383-30) / 1 SPRAY in 1 BOTTLE, SPRAY10 Jan, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose nasal decongestant

Product Elements:

Oxymethazoline hcl oxymethazoline hcl sodium phosphate, monobasic, anhydrous edetate sodium propylene glycol benzalkonium chloride sodium phosphate, dibasic, anhydrous polyethylene glycol, unspecified oxymetazoline hydrochloride oxymetazoline water povidone, unspecified

Indications and Usage:

Uses temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes

Warnings:

Warnings 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 prduct do not use more than directed do not use 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, sneexing, or an increased nasal discharge may occur use of this container by more than one person may spread infection

Dosage and Administration:

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 10-12 hours. do not exceed 2 doeses in 24 hours. children under 6 years of age: ask a doctor. instructions for use: shake well before use. to open, rotate cap to align the marks. squeeze cap on toh sides in a counter-clockwise turn and pull to remove. to spray, hold bottles with thumb at base and nozzle between first and second fingers. without tilting the head, insert nozzle into nostril. fully depress rim with a firm even stroke and sniff deeply. wipe nozzle clean after use and snap cap back onto bottle.

Stop Use:

Stop use and ask a doctor if symptoms presist

Package Label Principal Display Panel:

Ndc 71205-383-30 reliabel-1 laboratories 12 hour decongestant nasal spray oxymetazoline hcl pump mist anti-drip rapid & powerful congestion relief 12 hour relief 1 fl oz (30 ml) 71205-383-30

Further Questions:

Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm et, monday - friday


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.