FDA.reportPublic FDA data

Sore Throat Relief Spray

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC. | Seaway Pharma Inc.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:42:44

Label at a glance#

ProductPHENOL
Active ingredientPHENOL
Label structure11 sections

Indications and uses

For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.

Dosage and administration

Adults and children 3 years of age and older. Apply to the affected area (one spray)  Allow to remain in place for at least 15 seconds, then spit out  Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age , consult a doctor or dentist Before using the first time, remove the protective neck band and dust...

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient                         Purpose

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%............. Oral Anesthetic/Analgesic

OTC - PURPOSE SECTION

Sore Throat Relief

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

Sore throat waring: Severe and persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Whan using this product do not exceed recommended dose. Do not use more than 2 days. Use only as directed. Use of this container by more
than one person may spread infection.

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

  • sore throat symptoms do not improve in 7 days 
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 3 years of age and older.

  • Apply to the affected area (one spray) 
  • Allow to remain in place for at least 15 seconds, then spit out 
  • Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age, consult a doctor or dentist
  • Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the
    nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, FD&C Red #40, glycerin, purified water, sodium saccharin.

SPL UNCLASSIFIED SECTION

  • Tamper Evident: Do not use if printed shrink band is broken or missing.
  • This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic.

Questions or comments?
call 866-200-8310 (Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC-83324-031-06

containerlabelcontainerlabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-031-06PHENOL177 mL in 1 BOTTLE, SPRAYSPRAY1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-031PHENOL SPRAY [CHAIN DRUG MARKETING ASSOCIATION INC.]1Current NDC, 1 package rows20241215_2379e23a-72fe-4e94-9d7e-9b623c0db174.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-03183324-031-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
SODIUM SACCHARINSB8ZUX40TYIACT
WATER059QF0KO0RIACT

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
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
ndc (package): 83324-031-06
ndc (product): 83324-031
ndc11 (package): 83324003106
spl id: 0a2c03b7-8e56-469e-af74-14495e2dd410
spl set id: 2379e23a-72fe-4e94-9d7e-9b623c0db174

Reported adverse events (FAERS/openFDA)#

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