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  4. NDC Product Code: 84010-058 Dermfree Original Nasal

NDC 84010-058 Dermfree Original Nasal

Naphazoline Hcl 0.05%original Nasal Spray Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 84010-058?
  4. Dermfree Original Nasal Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 84010-058 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
84010-058
Proprietary Name:
Dermfree Original Nasal
Non-Proprietary Name: [1]
Naphazoline Hcl 0.05%original Nasal
Substance Name: [2]
Naphazoline Hcl
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
Jiangxi Hemei Pharmaceutical Co., Ltd
Labeler Code:
84010
Product Label ID:
299818d2-f4f9-80f8-e063-6394a90af6cf
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
12-19-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 84010-058?

The NDC code 84010-058 is assigned by the FDA to the product Dermfree Original Nasal which is a human over the counter drug product labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. The generic name of Dermfree Original Nasal is naphazoline hcl 0.05%original nasal. The product's dosage form is spray and is administered via nasal form. The product is distributed in a single package with assigned NDC code 84010-058-01 30 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Dermfree Original Nasal?

Adults&children 6 years & 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. Ask a doctor: children 2 to under 6 years, Do not use children under 2 years. Shake well before use. Before using the first time, remove the protective cap & safely clip from the tip and prime metered pump by depressing 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 depresspump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

What are Dermfree Original Nasal Active Ingredients?

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.

Which are Dermfree Original Nasal UNII Codes?

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

Which are Dermfree Original Nasal Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Dermfree Original Nasal?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".