NDC 81577-6000 Orak-100

Hydrogen Peroxide

NDC Product Code 81577-6000

NDC 81577-6000-6

Package Description: 240 mL in 1 BOTTLE

NDC Product Information

Orak-100 with NDC 81577-6000 is a a human over the counter drug product labeled by Joaquin Armando Cardenas Urquidez. The generic name of Orak-100 is hydrogen peroxide. The product's dosage form is solution and is administered via buccal form.

Labeler Name: Joaquin Armando Cardenas Urquidez

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug 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.

Orak-100 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROGEN PEROXIDE .000005 mL/mL
  • HYPOCHLOROUS ACID .000015 mg/mL
  • SODIUM HYPOCHLORITE .000004 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Buccal - Administration directed toward the cheek, generally from within the mouth.

Product Labeler Information

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

Labeler Name: Joaquin Armando Cardenas Urquidez
Labeler Code: 81577
FDA Application Number: part333A 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 03-10-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Orak-100 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient Section

ACTIVE INGREDIENTSHypochlorous acidSodium hypochloriteHydrogen peroxide

Inactive Ingredients

WATER

Purpose Section

PURPOSE ANTISEPTIC

Dosage And Administration

Before using Diabek-100 oropharyngeal antiseptic, wash and rinse your mouth then place 15 ml of Diabek-100 in your mouth and rinse or gargle.

Indications And Usage

Rinse mouth with Diabek-100 for 1 min and then spit, it is not necessary to rinse with water.Gargle: Gargle 2 or 3 times with Diabek-100 for 30 seconds and then spit, it is not necessary to rinse with water.Perform this procedure 2 or 3 times a day for as long as indicated by your doctor

Warnings And Precautions

Discontinue use in case of irritation, local discomfort, or hypersensitivity to the components of Diabek-100.

Warnings

Keep in a cool place and away from direct sunlight.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Ask Doctor Section

In case of accidental ingestion consult your doctor.

Stop Use Section

Discontinue use in case of irritation, local discomfort, or hypersensitivity to the components of Diabek-100.

* Please review the disclaimer below.