FDA.reportPublic FDA data

Thergy

Manufacturer
Anjon Biologics, Inc.
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:10

Label at a glance#

ProductThergy
Active ingredientTHYMOL
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

​ ​Active Ingredients

Thymol 0.05%

OTC - PURPOSE SECTION

​Purpose​​

Oral Analgesic/Antimicrobial

INDICATIONS & USAGE SECTION

​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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

​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.

SPL UNCLASSIFIED SECTION

​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.

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

thergy labelthergy label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053171thymol 0.05 % Topical SprayPSN3
1053171thymol 0.5 MG/ML Topical SpraySCD3
1053171thymol 0.05 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69148-002-002024-01-30C16284748780-1d6a99b39-d4de-a426-e053-dadaa90af4c2ANJON BIOLOGICS - THERGY (69148-002)
69148-002-002022-01-31C16284748780-1d6a99b39-d4de-a426-e053-dadaa90af4c2ANJON BIOLOGICS - THERGY (69148-002)
69148-002-002022-01-28C16284748780-1d6a99b39-d4de-a426-e053-dadaa90af4c2ANJON BIOLOGICS - THERGY (69148-002)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69148-002-00Thergy15 mL in 1 BOTTLE, SPRAYSPRAY153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69148-002THERGY (THYMOL) SPRAY [ANJON BIOLOGICS, INC.]3Legacy NDC, 1 package rows20220210_fd31d290-8d33-4cec-8767-f9c20f5f067f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69148-00269148-002-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROTON LECHLERI WHOLE9K50DM06ORIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA LEAFGH32M797Y9IACT
HONEYY9H1V576FHIACT
LAVANDULA ANGUSTIFOLIA WHOLE51217XIL5LIACT
SALVIA OFFICINALIS WHOLEM9C36LC10EIACT
THYMOL3J50XA376EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6fed19f-8f02-bfb4-e053-2a95a90a7fc6fd31d290-8d33-4cec-8767-f9c20f5f067f2022-02-01WarningsExact identifier
spl id: d6fed19f-8f02-bfb4-e053-2a95a90a7fc6
spl set id: fd31d290-8d33-4cec-8767-f9c20f5f067f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.