FDA.reportPublic FDA data

Sore Throat

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2024-06-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:00:45

Label at a glance#

ProductSore Throat Cherry
Active ingredientPHENOL
Label structure10 sections

Indications and uses

temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation

Dosage and administration

adults and children 6 years of age and older apply to affected area (one spray) allow to remain in place for at least 15 seconds, than spit out use every 2 hours as directed by a doctor or dentist children under 12 years of age should be supervised in the use of this product children under 6 years of age, consult a doctor or dentist

Storage and handling

store between 20º-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic/Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dose.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years of age and older
    • apply to affected area (one spray)
    • allow to remain in place for at least 15 seconds, than spit out
    • use every 2 hours as directed by a doctor or dentist
  • children under 12 years of age should be supervised in the use of this product
  • children under 6 years of age, consult a doctor or dentist

Other information

STORAGE AND HANDLING SECTION

  • store between 20º-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, FD&C red #40, glycerin, flavor, purified water, saccharin sodium

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-932-7948

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Chloraseptic® active ingredient*

Sore Throat Spray

Phenol 1.4%

Oral anesthetic/analgesic

Relieves Sore Throat

ALCOHOL 0.10%

ASPIRIN FREE

SUGAR FREE

Cherry Flavor

FL OZ (mL)

†This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 95344 USA

supervaluprivatebrands.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE Sore Throat Spray Cherry Flavor
EQUALINE Sore Throat Spray Cherry Flavor

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-37641163-376-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVACTIB
ALCOHOL3K9958V90MIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
3567e246-8dbd-46b7-9541-fe6c112129d7db2f84cf-43e8-40f6-9090-52f307ef7f052024-06-13WarningsExact identifier
spl id: 3567e246-8dbd-46b7-9541-fe6c112129d7
spl set id: db2f84cf-43e8-40f6-9090-52f307ef7f05

Reported adverse events (FAERS/openFDA)#

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