FDA.reportPublic FDA data

Sore throat

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:37

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, then 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 20-25ºC (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. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

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

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, then 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 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient of Chloraseptic®*

Sore Throat Throat

Phenol 1.4%

Oral Anesthetic/Analgesic

Relieves Sore Throat

Works on Contact

ALCOHOL 0.10%

SUGAR FREE

CHERRY FLAVOR

FL OZ (mL)

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

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

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL HEALTH Sore Throat Spray Cherry Flavor
DOLLAR GENERAL HEALTH Sore Throat Spray Cherry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198776phenol 1.4 % Mucosal SprayPSN4
198776phenol 14 MG/ML Mucosal SpraySCD4
198776phenol 1.4 % Mucosal SpraySY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-376-06Sore throatcherry177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-376SORE THROAT CHERRY (PHENOL) SPRAY [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]4Current NDC, Legacy NDC, 1 package rows20231011_de634cf1-ed39-4d8a-8855-006c69b7aee9.zip

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
55910-37655910-376-06

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
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
ndc (package): 55910-376-06
ndc (product): 55910-376
ndc11 (package): 55910037606
spl id: 9ca7888c-aa54-47b6-a040-fe6d74566350
spl set id: de634cf1-ed39-4d8a-8855-006c69b7aee9

Reported adverse events (FAERS/openFDA)#

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