NDC 69148-002 Thergy
Thymol Spray Oral

Product Information

Product Code69148-002
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Thergy
Non-Proprietary Name 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.
Thymol
Product Type 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.
Human Otc Drug
Dosage FormSpray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Anjon Biologics, Inc.
Labeler Code69148
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-09-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 69148-002-00

Package Description: 15 mL in 1 BOTTLE, SPRAY

Product Details

Thergy is a human over the counter drug product labeled by Anjon Biologics, Inc.. The generic name of Thergy is thymol. The product's dosage form is spray and is administered via oral form.


What are Thergy Active Ingredients?

The following is the list of active ingredients in 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.


NDC to RxNorm Crosswalk

What is RxNorm? 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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • CROTON LECHLERI WHOLE (UNII: 9K50DM06OR)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)
  • HONEY (UNII: Y9H1V576FH)
  • LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
  • SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E)


* Please review the disclaimer below.

Thergy Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Drug Facts

​Active Ingredients

Thymol 0.05%


Otc - Purpose



​Purpose

Oral Analgesic/Antimicrobial


Indications & Usage



​Uses:​ ​Relieves sore throat pain, pain associated with canker sores, inflamed throat and mouth tissue, encourage healing of irritated mouth and throat sores and helps to reduce infection.


Warnings



​Warnings: Stop use and ask your dentist or doctor if swelling, rash or fever develops.


Otc - Keep Out Of Reach Of Children



​Keep out of reach of children​Do not administer to children under 3 years of age unless directed by your doctor.​


Dosage & Administration



​Directions​: For oral use only as directed by your health care professional. Shake gently prior to each use. Open mouth wide and insert applicator into mouth. Spray 2 to 3 pump sprays into mouth and throat area then swallow. Repeat every few hours or as needed.


Other



​Other Information for cancer patients:​ For use by cancer patients being treated with chemotherapy and/or radiation. For relief of lesions of the oral cavity associated with Muscositis. Safe and effective treatment for muscitis pain in patients with cancer. Spray in mouth, let stand for a few seconds then swallow.

​Other Information:​ This formula is dark red in color and may temporarily color the mouth area. This is normal.


Storage And Handling



Store between 20-25 °C (68-77°F). Do not refrigerate


Inactive Ingredient



​Inactive Ingredients:​​​ Croton Lechleri, Deionized Water, Glycerin, Glycyrrhiza Leaf Extract, Honey, Lavandula Angustifolia Extract, Salvia Officinalis


Package Label.Principal Display Panel




* Please review the disclaimer below.