Styptstix Stick
NDC 0404-1000

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0404-1000?
  4. Styptstix Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Styptstix (silver nitrate applicator) is a UNAPPROVED DRUG OTHER-approved product labeled by Henry Schein Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a stick for topical administration. This product entry covers the primary NDC 0404-1000 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0404-1000
Proprietary Name:
Styptstix
Non-Proprietary Name: [1]
Silver Nitrate Applicator
Substance Name: [2]
Silver Nitrate; Potassium Nitrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Stick - A dosage form prepared in a relatively long and slender often cylindrical form.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Henry Schein Inc.
Labeler Code:
0404
Product Label ID:
b7634e27-3c75-4e56-ab42-3e5796edb0c7
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
06-01-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0404-1000?

The NDC code 0404-1000 is assigned by the FDA to the product Styptstix. It is commonly known by its generic name, silver nitrate applicator. This pharmaceutical product is labeled by Henry Schein Inc. and is currently categorized as listed product. The medication is a stick administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0404-1000-03. 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?

INDICATIONS:  For cauterization of skin or mucous membrane and for removing warts and granulated tissue.DIRECTIONS:  The healthcare professional moistens the applicator tip with distilled water and applies the tip to the affected area.  The strength of the action is controlled by the dilution with distilled water. One StyptStix applicator is generally sufficient for each application.

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.
  • SILVER NITRATE 12.74 mg/1 - A silver salt with powerful germicidal activity. It has been used topically to prevent OPHTHALMIA NEONATORUM.
  • POTASSIUM NITRATE 38.21 mg/1 - RN given refers to cpd with MF of K-HNO3; when combined with charcoal and sulfur it can form EXPLOSIVE AGENTS

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:

What is the NDC to RxNorm Crosswalk for this product?

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:
  • RxCUI: 1117536 - potassium nitrate 25 % / silver nitrate 75 % Medicated Pad
  • RxCUI: 1117536 - potassium nitrate 250 MG/ML / silver nitrate 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - K+ nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - Pot nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated Pad
  • RxCUI: 1117536 - potassium nitrate 25 % / silver nitrate 75 % Topical Sponge

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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 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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".