FDA.reportPublic FDA data

NICE SORE THROAT Cherry

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:24

Label at a glance#

ProductNICE SORE THROAT Cherry
Active ingredientPHENOL
Label structure9 sections

Indications and uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Dosage and administration

apply to the affected area 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 age dose adults and children 12 years of age and older for each application, spray 5 times children 3 to under 12 years should be supervised in use of this product; for each application, spray 3 times children under 3 years of age consult a doctor or dentist

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurposes
Phenol 1.4%Oral Anesthetic/ Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Warnings

WARNINGS SECTION

Sore throat warning:Severe or 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 doctor.

OTC - WHEN USING SECTION

When using this productdo not use more than directed.

Stop use and ask a 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
  • difficulty in breathing occurs

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

Keep this and all drugs out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply to the affected area
  • 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
agedose
adults and children 12 years of age and olderfor each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product;

for each application, spray 3 times

children under 3 years of ageconsult a doctor or dentist

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature

TAMPER EVIDENT:DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, sodium saccharin, and water.

Questions?

OTC - QUESTIONS SECTION

1-855-452-9500or email at info@leosonsintl.com

Distributed by:

SPL UNCLASSIFIED SECTION

LEOSONS
Albany, New York 12205

MADE IN THE USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • Sugar Free
  • Alcohol Free
  • Aspirin Free

N'ICE®

PHENOL/ ORAL ANESTHETIC

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

Cherry Flavor

6 FL OZ (177 mL)

NICE Throat CherryNICE Throat Cherry

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69626-0047-62024-11-15C16284748780-10191ceaa-6525-198a-e063-dbdaa90aec3eNICE Sore Throat Cherry
69626-0047-62023-07-28C16284748780-10191ceaa-6525-198a-e063-dbdaa90aec3eNICE Sore Throat Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0047-6NICE SORE THROAT Cherry177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0047NICE SORE THROAT CHERRY (PHENOL) SPRAY [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 1 package rows20241116_5f21694c-d1c9-0e64-e053-2a91aa0a0ff0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-004769626-0047-6

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
SACCHARIN SODIUMSB8ZUX40TYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOL339NCG44TVACTIB

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
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
ndc (package): 69626-0047-6
ndc (product): 69626-0047
ndc11 (package): 69626004706
spl id: 26f75afb-46ec-926b-e063-6394a90ac440
spl set id: 5f21694c-d1c9-0e64-e053-2a91aa0a0ff0

Reported adverse events (FAERS/openFDA)#

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