Nasal
Phenylephrine Hydrochloride
Walgreen Company
Human Otc Drug
NDC 0363-0717Nasal also known as Phenylephrine Hydrochloride is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Nasal is 0363-0717. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Nasal drug includes Phenylephrine Hydrochloride - 1 g/100mL . The currest status of Nasal drug is Active.
Drug Information:
| Drug NDC: | 0363-0717 |
| 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: | Nasal |
| 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: | Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreen Company |
| 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: | PHENYLEPHRINE HYDROCHLORIDE - 1 g/100mL
|
| 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: | 31 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | Walgreen Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1087043
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0363-0717-10 | 1 BOTTLE in 1 CARTON (0363-0717-10) / 29.6 mL in 1 BOTTLE | 31 Jan, 2022 | N/A | No |
| 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:
Nasal phenylephrine hydrochloride phenylephrine hydrochloride phenylephrine benzalkonium chloride benzyl alcohol boric acid sodium borate water
Indications and Usage:
Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies
Warnings:
Warnings ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure 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. frequent or prolonged use may cause nasal congestion to come back or get worse. use only as directed 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 stop use and ask a doctor if symptoms persist if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
When Using:
When using this product do not use more than directed do not use for more than 3 days. frequent or prolonged use may cause nasal congestion to come back or get worse. use only as directed 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
Dosage and Administration:
Directions adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours children under 12 years: ask a doctor use instructions: with head in a normal, upright position, put atomizer tip into nostril. squeeze bottle with firm, quick pressure while inhaling. wipe nozzle clean after each use.
Stop Use:
Stop use and ask a doctor if symptoms persist
Package Label Principal Display Panel:
Principal display panel walgreens walgreens pharmacist recommended compare to the active ingredient in 4 way ® nasal spray nasal spray phenylephrine hydrochloride 1% / nasal decongestant for fast relief of nasal congestion, swollen nasal membranes, sinus congestion & sinus pressure 1 fl oz (29.6 ml) nasal spray image
Further Questions:
Questions or comments? 1-800-719-9260