Vicks Sinex Severe Spray
NDC 64336-015

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64336-015?
  5. Vicks Sinex Severe Moisturizing Ultra Fine Mist Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Vicks Sinex Severe (oxymetazoline hydrochloride) is a OTC MONOGRAPH DRUG-approved product labeled by Procter & Gamble Manufacturing Gmbh. This medication is typically used as a imidazolines [cs]. It is supplied as a white spray for nasal administration. This product entry covers the primary NDC 64336-015 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64336-015
Proprietary Name:
Vicks Sinex Severe Moisturizing Ultra Fine Mist
Non-Proprietary Name: [1]
Oxymetazoline Hydrochloride
Substance Name: [2]
Oxymetazoline Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Nasal - Administration to the nose; administered by way of the nose.

Labeler & Regulatory Data

Labeler Name: [5]
Procter & Gamble Manufacturing Gmbh
Labeler Code:
64336
Product Label ID:
f4b01827-7444-3bfc-e053-2a95a90aebed
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
07-10-2018
End Marketing Date: [10]
02-28-2028
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR)

Code Structure Chart

Product Details

What is NDC 64336-015?

The NDC code 64336-015 is assigned by the FDA to the product Vicks Sinex Severe Moisturizing Ultra Fine Mist. It is commonly known by its generic name, oxymetazoline hydrochloride. This pharmaceutical product is labeled by Procter & Gamble Manufacturing Gmbh and is currently categorized as listed product. The medication is a spray administered via nasal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 64336-015-01, 64336-015-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.adults & children 6 yrs. & older (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 24 hours.children 2 to under 6 yrs.ask a doctorchildren under 2 yrs.do not use

What are Active Ingredients of 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.
  • OXYMETAZOLINE HYDROCHLORIDE .05 g/mL - A direct acting sympathomimetic used as a vasoconstrictor to relieve nasal congestion. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1251)

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

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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Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? 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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".