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NDC 50804-341 Ear Wax Removal Drops

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50804-341?
  4. Ear Wax Removal Drops Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50804-341
Proprietary Name:
Ear Wax Removal Drops
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Goodsense
Labeler Code:
50804
Product Label ID:
d96688fe-c47b-4762-bc2c-19ea9c44fd3e
FDA Application Number: [6]
part344
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
06-05-2019
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
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Product Details

What is NDC 50804-341?

The NDC code 50804-341 is assigned by the FDA to the product Ear Wax Removal Drops which is product labeled by Goodsense. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 50804-341-51 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper, 50804-341-61 1 bottle, dropper in 1 kit / 15 ml in 1 bottle, dropper. 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 Ear Wax Removal Drops?

Adults and children over 12 years of age:  Tilt head sideways and place 5 to 10 drops into ear.Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor.  Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.Children under 12 years:  consult a doctor.

Which are Ear Wax Removal Drops UNII Codes?

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

Which are Ear Wax Removal Drops 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 Ear Wax Removal Drops?

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

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".